QTGClass II
Infant Supine Sleep System
General Hospital · 21 CFR 880.5690
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).
MDR events10All time
Recalls1All time
Registered firms4Currently listed
510(k) clearances1All time
Recent MDR events
10 adverse event reports on file
- SNOO Smart SleeperJul 28, 2026MalfunctionHappiest Baby3030187577-2026-00005
- SNOO SMART SLEEPERApr 21, 2026InjuryHappiest Baby3030187577-2026-00004
- SNOO SMART SLEEPERApr 21, 2026InjuryHappiest Baby3030187577-2026-00003
- SNOO SMART SLEEPERFeb 27, 2026InjuryHappiest Baby3030187577-2026-00002
- SNOO SMART SLEEPERJan 14, 2026MalfunctionHappiest Baby3030187577-2026-00001
- SNOO SMART SLEEPERJun 23, 2025MalfunctionHappiest Baby3030187577-2025-00001
- SNOO SMART SLEEPER BASSINETMay 15, 2025MalfunctionHappiest Baby, Inc.MW5170420
- SNOO SMART SLEEPERDec 2, 2024InjuryHappiest Baby3030187577-2024-00001
- SNOOJun 25, 2024MalfunctionHappiest Baby, Inc.MW5156634
- SNOO SMART SLEEPERFeb 13, 2024InjuryHappiest Baby, Inc.MW5151566
Event type breakdown
Injury5
Malfunction5
Most-reported manufacturers
Recalls
1 recall events for this product code
Registered firms
4 firms currently registered for this product code
510(k) clearances
1 clearances for this product code