QTG

Infant Supine Sleep System

Product code

QTG

Device name

Infant Supine Sleep System

Device class

Class 2

21 CFR

21 CFR 880.5690

Medical specialty

General Hospital

Marketing pathway

510(K)

510(k) clearances (all years, FDA)

1 (all years; only the last 3 years are listed here)

FDA classification 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).

Definition text from the FDA device classification database (U.S. federal government work, public domain).