Device type
Infant Supine Sleep System
Product code QTG · Class II · 21 CFR 880.5690 · General Hospital
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).
Recent 510(k)s
No 510(k) clearances in the archive for QTG.
Recent recalls
Sep 23, 2026
Z-3176-2026
Happiest Baby, Inc. SNOO Sleep Sack, X-Large Model/Catalog Number: S2101-501 S2101-508-11 S2101-508-3 S2101-508-4 S2101-508-5 S2101-508-6 S2101-508-7 S2101-512…
Happiest Baby, Inc
- QTG
- Class II
- Ongoing
Sep 23, 2026
Z-3175-2026
Happiest Baby, Inc SNOO Sleep Sack, X-Small Model/Catalog Number: S2101-101 S2101-108-6 S2101-133 S2102-112 S2107-101 S2107-110
Happiest Baby, Inc
- QTG
- Class II
- Ongoing