510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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QTGClass II

Infant Supine Sleep System

21 CFR 880.5690 / General Hospital
FDA source (opens on fda.gov)

QTG is the FDA product code for Infant Supine Sleep System, a class II device type, regulated under 21 CFR 880.5690. FDA's definition for this code reads: "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)". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and one recall.

Classification record

Product code
QTG
Device name
Infant Supine Sleep System
FDA definition
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).
Regulation
21 CFR 880.5690
Device class
Class II
Review panel
General Hospital
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
3

Clearances, product code QTG

By decision year
1 clearance under product code QTG with a decision year between 2023 and 2023, 2023 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code QTG by decision year
YearClearances
20231

Applicants with the most clearances

Product code QTG
Applicants holding the most 510(k) clearances under product code QTG
ApplicantClearances
Happiest Baby, Inc1

Companies listing this code with FDA

Companies whose registered establishments list this code