DeviceClearance

Product code QTG— General Hospital

SNOO Smart Sleeper

Classification name
Infant Supine Sleep System
Device class
Class 2
Regulation
21 CFR 880.5690
Advisory panel
General Hospital
Total cleared
1
First cleared
Most recent

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).”

— U.S. Food and Drug Administration, device classification record for product code QTG under 21 CFR 880.5690, via openFDA

Market context for product code QTG

FDA has cleared 1 device under product code QTG, all in 2023, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code QTG

Recent clearances under product code QTG

Data sourced from openFDA. This site is unofficial and independent of the FDA.