What is FDA product code QTG?

An infant supine sleep system is a device intended to facilitate a supine position during sleep for use in infants that are not yet able to roll over consistently. Infants placed in a supine sleep position are at lower risk of sudden infant death syndrome (SIDS) or sudden unexpected infant death (SUID).

General Hospital › TherapeuticInfant Supine Sleep System

Snoo Smart Sleeper

Name: Snoo Smart Sleeper
Brand: Snoo Smart Sleeper

The SNOO Smart Sleeper bassinet plus the SNOO Sleep Sack are jointly intended to facilitate a supine position during sleep. Infants who are placed in a supine sleep position are at lower…

Registry build 21.09.26

The SNOO Smart Sleeper bassinet plus the SNOO Sleep Sack are jointly intended to facilitate a supine position during sleep. Infants who are placed in a supine sleep position are at lower risk of SIDS/SUID. The device is intended for home use by caregivers of infants from birth to 6 months of age, who are not yet able to roll over consistently.

1manufacturer

1catalogue number

1510(k) clearance

3recalls on this code

Who Else Makes It

Registered in Guangdong. One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code QTG
Manufacturer	City	Province	Registered as	Device types
Jetta (China) Industries Co., Ltd.	Guangzhou	Guangdong	Contract manufacturer	1

Record

Regulatory record for Snoo Smart Sleeper
Listed by	Happiest Baby, Inc., United States
FDA product code	QTG
Device type	Infant Supine Sleep System
Device class	Class 2
Regulation	21 CFR 880.5690
Establishment	Specification developer, Complaint-file establishment, Manufacturer
Premarket notification	Exempt
Record published	2024-07-11

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Over the counter	Yes
Label carries	lot or batch number

Catalogue Numbers

Catalogue numbers for Snoo Smart Sleeper
Catalogue number	Size	Status
S1000		In distribution

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
DEN210039	2023-03-30

Recalls

1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity
2026-08-07	Not classified	Device Design	Extra small (ES) and Extra-large (XL) infant sleep sacks have not been reviewed for safety and effectiveness by the FDA.	1055 units
2026-08-07	Not classified	Device Design	Extra small (ES) and Extra-large (XL) infant sleep sacks have not been reviewed for safety and effectiveness by the FDA.	14837
2024-05-15	Class II	Reprocessing Controls	This recall is retroactively being reported. Due to complaints, refurbished baby sleep sacks failed to meet quality standards before distribution appearing to be uncleaned.	4 units

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.