20 Best FDA Approved Infant Sleep Positioner in 2022 Reviews and Buying Guide

 

2,874 Reviews Scanned

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1 Nested Bean Zen Sack - Gently Weighted Sleep Sack, Baby: 6-15 Months, Help Newborn/Infant Swaddle... Nested Bean Zen Sack - Gently Weighted Sleep Sack, Baby: 6-15 Months, Help Newborn/Infant Swaddle... No ratings yet
2 haakaa Silicone Baby Nasal Aspirator| Safe Baby Nose Cleaner| Easy-Squeeze Nose & Ear Bulb Syringe,... haakaa Silicone Baby Nasal Aspirator| Safe Baby Nose Cleaner| Easy-Squeeze Nose & Ear Bulb... No ratings yet
3 Baby Merlin's Magic Sleepsuit - Microfleece Baby Transition Swaddle - Baby Sleep Suit - Blue - 6-9... Baby Merlin's Magic Sleepsuit - Microfleece Baby Transition Swaddle - Baby Sleep Suit - Blue -... No ratings yet
4 Baby Merlin's Magic Sleepsuit - 100% Cotton Baby Transition Swaddle - Baby Sleep Suit - Blue - 6-9... Baby Merlin's Magic Sleepsuit - 100% Cotton Baby Transition Swaddle - Baby Sleep Suit - Blue -... No ratings yet
5 Betterhood 5pcs Orthopedic Bed Wedge Pillow Set, Adjustable Memory Foam Pillows, Post Surgery Foam... Betterhood 5pcs Orthopedic Bed Wedge Pillow Set, Adjustable Memory Foam Pillows, Post Surgery... No ratings yet
6 Little Remedies Sterile Saline Nasal Mist, Safe for Newborns, 3 oz Little Remedies Sterile Saline Nasal Mist, Safe for Newborns, 3 oz No ratings yet
7 Pregnancy Wedge Pillow Pregnancy Wedge Pillow No ratings yet
8 MyBaby SoundSpa White Noise Machine for Babies | 6 Soothing Lullabies for Newborns, Sound Therapy... MyBaby SoundSpa White Noise Machine for Babies | 6 Soothing Lullabies for Newborns, Sound Therapy... No ratings yet
9 iKeener Sleep Aid Machine for Insomnia, Anxiety Depression Headache Reliever,Sleep Support Machine... iKeener Sleep Aid Machine for Insomnia, Anxiety Depression Headache Reliever,Sleep Support... No ratings yet
10 Windi Gas and Colic Reliever for Babies (10 Count) by Frida Baby Windi Gas and Colic Reliever for Babies (10 Count) by Frida Baby No ratings yet
11 Zarbee's Baby Sleep Spray, Calming Bedtime Spray with Natural Lavender and Chamomile to Help Infant... Zarbee's Baby Sleep Spray, Calming Bedtime Spray with Natural Lavender and Chamomile to Help... No ratings yet
12 BABYINABAG Summer Model Baby Sleeping Bag and Sack, Plush Minky Dot, 1.25 Togs, for Infants and... BABYINABAG Summer Model Baby Sleeping Bag and Sack, Plush Minky Dot, 1.25 Togs, for Infants and... No ratings yet
13 Baby Colic, Gas and Upset Stomach Relief, Baby Heated Tummy Wrap, Infant Swaddling Belly Belt with... Baby Colic, Gas and Upset Stomach Relief, Baby Heated Tummy Wrap, Infant Swaddling Belly Belt... No ratings yet
14 Baby Cold Medicine, Nighttime Infant Cold and Cough Medicine, Decongestant, Hyland's Baby Mucus and... Baby Cold Medicine, Nighttime Infant Cold and Cough Medicine, Decongestant, Hyland's Baby Mucus... No ratings yet
15 Baby Brezza Safe Sleep Swaddle Blanket for Crib Safety for Newborns and Infants – Safe,... Baby Brezza Safe Sleep Swaddle Blanket for Crib Safety for Newborns and Infants – Safe,... No ratings yet
16 Baby Shusher The Sleep Miracle Sound Machine Rhythmic Human Voice Shushes Baby to Sleep Every Time... Baby Shusher The Sleep Miracle Sound Machine Rhythmic Human Voice Shushes Baby to Sleep Every... No ratings yet
17 Mommy's Bliss Newborn Essentials Gift Set, Includes Gripe Water, Baby Vitamin D Drops, Baby Gas... Mommy's Bliss Newborn Essentials Gift Set, Includes Gripe Water, Baby Vitamin D Drops, Baby Gas... No ratings yet
18 WoodyKnows 2021 Newly Upgraded Side-Sleeping Backpack with All Magic Tape Straps and Enhanced Zipper... WoodyKnows 2021 Newly Upgraded Side-Sleeping Backpack with All Magic Tape Straps and Enhanced... No ratings yet
19 Boppy Nursing Pillow and Positioner—Original | Gray Taupe Watercolor Leaves | Breastfeeding,... Boppy Nursing Pillow and Positioner—Original | Gray Taupe Watercolor Leaves | Breastfeeding,... No ratings yet
20 Kiddiezoom Baby Girl 5-Pack Short-Sleeve Bodysuit Bodysuit Kiddiezoom Baby Girl 5-Pack Short-Sleeve Bodysuit Bodysuit No ratings yet

Bestseller No. 1
Nested Bean Zen Sack - Gently Weighted Sleep Sack, Baby: 6-15 Months, Help Newborn/Infant Swaddle...
  • HELP YOUR BABY SLEEP LONGER - Our gently weighted Zen Sack mimics the pressure your baby feels when held by you. Helping babies to self soothe & sleep...
  • MADE FOR BABIES ALL SHAPES, SIZES & STAGES (AGES 0 TO 24 MONTHS) - Whether you are looking to transition from a swaddle or the developmental changes...
  • PRODUCT INFO - The Zen Sack Classic is made from 100% Cotton and has a TOG rating of 0.5 which makes it perfect for year-round comfort. To learn more...
  • IMPORTANT FEATURES - Safe for all sleep types (back/side/tummy sleepers). 2-way zipper system allows easy diaper changes. A wearable blanket with...
  • SATISFACTION GUARANTEE - If at any point in time - for whatever reason - you should be dissatisfied with the Zen Sack - don’t hesitate to contact...
Bestseller No. 2
haakaa Silicone Baby Nasal Aspirator| Safe Baby Nose Cleaner| Easy-Squeeze Nose & Ear Bulb Syringe,...
  • ✔️ 100% food grade silicone - Soft and gentle for little noses.Suitable for newborns and up.BPA, Phthalate & Latex free
  • ✔️Two-piece design - Easy to use, reuse and disassemble for cleaning.
  • ✔️Helps to clear your baby’s airways and remove congestion with just a squeeze.
  • ✔️Easy to Adjust SuctionStrength - by gently squeezing the silicone body with more or less pressure.
  • ✔️Transparent body - clearly see how much mucus has been collected.
Bestseller No. 3
Baby Merlin's Magic Sleepsuit - Microfleece Baby Transition Swaddle - Baby Sleep Suit - Blue - 6-9...
  • The Baby Merlin's Magic Sleepsuit is the original swaddle transition product, created by a Pediatric PT and mom of 4.
  • Merlin's Magic Sleepsuit helps establish good sleep habits and provides parents peace of mind that their baby is getting adequate rest for proper...
  • The Magic Sleepsuit is designed for back sleeping in the crib at the recommended room temperature for babies. Proper fit and timing of introduction of...
  • The Baby Merlin's Microfleece Magic Sleepsuit has a soft and breathable jersey cotton inner layer, a soft microfleece outer layer and a layer of...
  • Double zipper for easy in/out and diaper changes. Machine wash cold with like colors, non-chlorine bleach as needed, tumble dry low or hang to dry. Do...
Bestseller No. 4
Baby Merlin's Magic Sleepsuit - 100% Cotton Baby Transition Swaddle - Baby Sleep Suit - Blue - 6-9...
  • The Baby Merlin's Magic sleepsuit is the original swaddle transition product.
  • The Baby Merlin's Magic sleepsuit helps establish good sleep habits and provides parents peace of mind that their baby is getting adequate rest for...
  • The sleepsuit is designed for back sleeping in the crib at the recommended room temperature for babies. Proper fit and timing of introduction of the...
  • The Baby Merlin's Cotton Magic sleepsuit has a soft and breathable jersey cotton inner layer, a soft cotton outer layer and a layer of polyfil in...
  • Double zipper for easy in/out and diaper changes. Machine wash cold with like colors, non-chlorine bleach as needed, tumble dry low or hang to dry. Do...
SaleBestseller No. 5
Betterhood 5pcs Orthopedic Bed Wedge Pillow Set, Adjustable Memory Foam Pillows, Post Surgery Foam...
  • 💪【Premium Quality】Our Orthopedic Bed Wedge Pillow Set combines with premium memory foam on top and firm foam for base, which provide ultimate...
  • 💪【Multifunction Pillow Set】 The Betterhood bed wedge pillow set helps to release yourself. It can keep your head, shoulders, trunk or legs and...
  • 💪【Support Whole Body】 The Betterhood wedge pillow set contains 5 parts of various sizes and shapes to suitable for any positions, helps you get...
  • 💪【Flexible Adjustment】 Scientific ergonomic design for women and men of any height. Adjustable design makes it can be placed at anywhere...
  • 💪【Perfect Gift Choice】 If you're looking for something that can improve your happiness and health, this is an ideal post-surgery recovery gift...
SaleBestseller No. 6
Little Remedies Sterile Saline Nasal Mist, Safe for Newborns, 3 oz
  • Relieves runny, stuffy, dry or crusty noses and keeps baby's nose clear and moisturized
  • Sterile saline mist flushes mucus from little noses
  • Non-medicated relief that safely soothes
  • Contains no alcohol and is drug- and preservative-free
  • Safe for newborns
Bestseller No. 7
Pregnancy Wedge Pillow
  • 💛 SLEEP BETTER, BREATHER EASIER
  • 💛 RELIEF OF CONGESTION & REFLUX
  • 💛 UNIVERSAL SIZE
SaleBestseller No. 8
MyBaby SoundSpa White Noise Machine for Babies | 6 Soothing Lullabies for Newborns, Sound Therapy...
  • 6 Soothing Sounds: Choose from 6 relaxing sounds: Heartbeat, White Noise, Cradle, Ocean, Brook, and Summer Night; the adjustable volume setting allows...
  • Compact & Portable: With a small and lightweight design, it easily fits into your purse, bag, or suitcase; create a familiar sleeping environment for...
  • Help Baby Sleep & Relax: Soothing sounds that mimic the natural environment will help lull your baby to sleep faster and stay asleep longer whether...
  • Auto-Off Timer: The timer features 3 options: 15, 30, or 60 minutes; it can be plugged into a wall outlet with the adapter (included) or powered by 4...
  • What’s in the Box: (1) MyBaby SoundSpa Portable White Noise Machine, (1) AC Adapter, (1) Quick-Start Guide
Bestseller No. 9
iKeener Sleep Aid Machine for Insomnia, Anxiety Depression Headache Reliever,Sleep Support Machine...
  • ❓Do You Have the Following Trouble? Tossing and turning all night,households with difficulty getting up,Poor mood,grumpy and irritable,poor sleep...
  • 💤【35 Levels of Intensity Can Be Adjusted】Pure Physical Cure——No dependency;No-Drug Stimulation——No damage to the metabolism;No-Side...
  • 📌【Preparation for Use】When you receive the device,Take out host and accessories.thoroughly clean and wet the skin of application area(ear) to...
  • 💪【Intelligent Countdown】The automatic shutdown timer is 15 minutes. When you restart the device, click the time button. (Different use time and...
  • 🤘【HD Full Light-Transmitting Touch Screen】Large and clear font, intuitive, simple operation, easy to use.
SaleBestseller No. 10
Windi Gas and Colic Reliever for Babies (10 Count) by Frida Baby
  • INVENTED BY A PEDIATRIC GASTROENTEROLOGIST: A hollow tube that safely, naturally and instantly relieves gas and calms colic.
  • DESIGNED FOR YOUR BABY'S BOTTOM: The Windi is long enough to reach past the muscle that traps the gas and stimulate the sphincter, but has a stopper...
  • ALL NATURAL GAS & COLIC RELIEF: No drops or ingestible needed, making the Windi a great alternative.
  • SAFE + SANITARY: BPA + Latex-Free.
  • 1 PACK: 10 Single-use gas relief tubes.
SaleBestseller No. 11
Zarbee's Baby Sleep Spray, Calming Bedtime Spray with Natural Lavender and Chamomile to Help Infant...
  • CALMING SPRAY FOR BABIES: A great addition to baby’s sleep routine, this Calming Spray is made with lavender and chamomile to help relax and prepare...
  • SAFE & EFFECTIVE: Packaged in an easy-to-use spray bottle, this safe and effective room spray features essential oils known for their comforting...
  • INGREDIENTS INSPIRED BY NATURE: Our Baby Calming Bedtime Spray is made from carefully selected ingredients inspired by nature – free of artificial...
  • PEDIATRICIAN APPROVED: Zarbee’s was developed by father and pediatrician, Dr. Zak Zarbock. #1 Pediatrician Recommended Sleep Support Brand for Kids.
  • FOR THE LOVE OF BABY WELL-BEEING: Check out our complete range of products made just for babies. *These statements have not been evaluated by the Food...
Bestseller No. 12
BABYINABAG Summer Model Baby Sleeping Bag and Sack, Plush Minky Dot, 1.25 Togs, for Infants and...
  • SIZING: Please measure your little one from head to toe and match the length of your baby with the corresponding size next to it on our sizing chart....
  • SAFE SLEEP: Baby sleeping bags should be sleeveless to aid the heat loss and air circulation. Babies sleeping under traditional blankets rarely sleep...
  • HIGH QUALITY: This is a 1.25 Tog Summer Model baby sleeping bag for room temperatures above 70 F. Minky Dot outer shell and 100% Jersey cotton inner...
  • SPACIOUS AND PRACTICAL: Generous bell shape sack design allows ample room for kicking, but cannot be kicked off so baby stays warm all night. If...
  • SUMMER WEIGHT: This is a warm summer model with its intended use in air-conditioned homes. The recommended nursery temperatures should be above 70F...
SaleBestseller No. 13
Baby Colic, Gas and Upset Stomach Relief, Baby Heated Tummy Wrap, Infant Swaddling Belly Belt with...
  • 🐘【Instant Relief for Gassy or Colicky Babies】 CUCKOOL Baby Belly Warming Wrap provides fast and timely relief to upset stomach, relieving...
  • 🐘【Safe Alternative to Medications and Drops】 For parents who are worried that medications may contain untested ingredients, this external...
  • 🐘【Practical for Frequent and Multiple Uses】 The heated infant belly pouch provides soft and gentle compression to baby's upset tummy, the...
  • 🐘【Long-lasting and Resistant Gel Pack】 The premium, fabric-covered gel pack is durable and microwave-safe for repeated use. No microwave?...
  • 🐘【The Immediate Natural Treatment at Home】 Effectively relieve your baby from frequent colic or gassy tummy, convenient especially in the night...
SaleBestseller No. 14
Baby Cold Medicine, Nighttime Infant Cold and Cough Medicine, Decongestant, Hyland's Baby Mucus and...
  • NIGHTTIME RELIEF OF MUCUS & COLD: Natural relief of colds, including accumulation of mucus in chest, throat and nose, cough with expectoration of...
  • EASY TO USE: Dosing syringe for easy delivery in mouth to relieve congestion, runny nose, cough and loosening of mucus, irritability, fussiness and...
  • 4 FL OZ = UP TO 47 DOSES of Hyland's Baby Nighttime Mucus + Cold Relief syrup
  • NATURAL MEDICINE: Naturally provides up to 71% of the daily value. Hyland's is committed to providing natural solutions for families at every stage of...
  • SAFE AND RELIABLE: Homeopathy is a safe system of medicine with fundamental principles for selection and application, working to stimulate the body's...
Bestseller No. 15
Baby Brezza Safe Sleep Swaddle Blanket for Crib Safety for Newborns and Infants – Safe,...
  • Helps your baby sleep safely and you sleep without worry
  • Unique sleep swaddler comfortably secures your baby on their back during sleep (which is recommended by the American Academy of Pediatrics)
  • Reduces risk of rolling over, tummy sleeping and falling or climbing out of the crib; Easy to secure to your mattress and baby with Velcro
  • Ideal for babies with reflux when used in conjunction with a crib wedge
  • Fits all standard size crib mattresses & mini-mattresses. Machine washable; 100% cotton; Recommended for babies 0-9months/7-25 lbs
Bestseller No. 16
Baby Shusher The Sleep Miracle Sound Machine Rhythmic Human Voice Shushes Baby to Sleep Every Time...
  • Using a real human voice, lull your baby to sleep with a calming shush — freeing up your precious time. Baby Shusher is the only baby soother needed...
  • 15 to 30-minute timers assure long shushing sessions can get even the most resistant babies to sleep. Baby Shusher can be placed on the changing table...
  • Adjustable volume control helps your baby get to sleep without keeping everyone else awake. The device is one of the essential crib accessories to...
  • Portable, easy-to-use design, and removable wrist strap gives you the option to carry your baby while putting them to sleep, and comes with 2 AA...

  • Baby Shusher is the award winning sleep aid device with awards such as: Mom's Choice Award, Parent Tested Parent Approved (PTPA), OHbaby! 2018...
Bestseller No. 17
Mommy's Bliss Newborn Essentials Gift Set, Includes Gripe Water, Baby Vitamin D Drops, Baby Gas...
  • Mommy’s Bliss Newborn Essentials Gift Set takes out the guesswork with our most-requested rescues for those early days. Makes a perfect gift for...
  • Gripe Water Original: Designed for babies 2 weeks and older, is gentle, safe, and effective with organic ginger and fennel extracts that ease your...
  • Organic Baby Vitamin D Drops: Contains 400IU of vitamin D3 per serving as recommended by the American Academy of Pediatricians promotes healthy growth...
  • Fast-acting Baby Gas Relief Drops with simethicone: A Pediatrician recommended solution for relieving gas quickly in newborns and older, with natural...
  • Saline Drops/Spray: Provides nasal relief for newborns with a gentle and effective solution to clear mucus, clean, moisturize, and soothe delicate...
SaleBestseller No. 18
WoodyKnows 2021 Newly Upgraded Side-Sleeping Backpack with All Magic Tape Straps and Enhanced Zipper...
  • Helps with Side-Sleeping - This backpack provides comfortable back support to help you sleep on your side so that the tongue, soft palate, and relax...
  • Big Enough to Ensure Side-Sleeping - This backpack is big enough and keeps you off your back at night. Imagine what will happen if the back supporter...
  • Stable and Comfortable at Night - This backpack features a three-point fixation design at both shoulders and waist, which disperses the pressure of...
  • 2021 NEWLY UPGRADED MODEL - All buckles have been replaced by magic tape to prevent slipping out and discomfort. The connection at the root of the...
  • Size Guide - Two sizes are available. Measure your back width between your armpits but not including your arms. Large size for back width larger than...
SaleBestseller No. 19
Boppy Nursing Pillow and Positioner—Original | Gray Taupe Watercolor Leaves | Breastfeeding,...
  • VERSATILE AWAKE-TIME SUPPORT: Feeding (0+ months), propping (3+ months), tummy time (6+ months) and sitting (9+ months). For baby’s awake time only....
  • CREATED FOR COMFORT: Designed by a mom, the Boppy Pillow provides relief to your arms and back by lifting your baby to a more ergonomic position when...
  • YOU HAVE OPTIONS: Works for multiple feeding styles—cradle, cross cradle, football hold, bottle feeding
  • REMOVABLE SLIPCOVER: Comes dressed in a removable pillow cover with an easy-on covered zipper design
  • EASY CARE, MACHINE WASHABLE: The Boppy Pillow and slipcover are machine washable because messes happen
Bestseller No. 20
Kiddiezoom Baby Girl 5-Pack Short-Sleeve Bodysuit Bodysuit
  • Machine Wash
  • Pull-on closure
  • Soft organic cotton rib
  • Optimal for everyday use
  • Higher-in-the-front bottom snap closure for easy changing
.

FAQ:

Q: Are sleep positioners safe for babies?

A: You can do your part to keep your baby safe by not using sleep positioners. You can report an incident or injury from an infant sleep positioner to the FDA’s MedWatch program. And you can find more advice about baby products on the FDA’s website.

Q: Are infant positioners FDA approved for SIDS?

A: The FDA had previously cleared some infant positioners for GERD or flat head syndrome. In 2010, the FDA became aware of infant positioners being marketed with SIDS claims and notified manufacturers to stop marketing these devices and submit information to support FDA clearance.

Q: Are sleep positioners regulated by the FDA?

A: Sleep positioners that do not meet the definition of a medical device may be regulated by the Consumer Product Safety Commission. Some types of sleep positioners can feature raised supports or pillows (called “bolsters”) that are attached to each side of a mat, or a wedge to raise a baby’s head.

Q: Are inclined sleep products safe for infants?

A: CPSC hired independent expert Erin Mannen, Ph.D., a mechanical engineer specializing in biomechanics at the University of Arkansas for Medical Sciences, to conduct infant testing to evaluate the design of inclined sleep products. Dr. Mannen found that none of the inclined sleep products her team tested is safe for infant sleep.