QTG · Class II · 21 CFR 880.5690

FDA Product Code QTG: Infant Supine Sleep System

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).

Leading manufacturers include Happiest Baby, Inc..

1
Total
0
Cleared
556d
Avg days
2023
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Infant Supine Sleep System Devices (Product Code QTG)

1 devices
1–1 of 1
Not Cleared Mar 30, 2023
SNOO Smart Sleeper
DEN210039
Happiest Baby, Inc.
General Hospital · 556d

About Product Code QTG - Regulatory Context

510(k) Submission Activity

1 total 510(k) submissions under product code QTG since 2023, with 0 receiving FDA clearance (average review time: 556 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.