# DEN210039: SNOO Smart Sleeper

- Pathway: De Novo (Direct)
- Applicant: Happiest Baby, Inc.
- Decided: Mar 30, 2023 after 556 days
- Product code: QTG (Infant Supine Sleep System)
- Device class: 2
- Regulation: 21 CFR 880.5690
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Indications for use
The SNOO Smart Sleeper bassinet plus the SNOO Sleep Sack are jointly intended to facilitate a supine position during sleep. Infants who are placed in a supine sleep position are at lower risk of SIDS/SUID. The device is intended for home use by caregivers of infants from birth to 6 months of age, who are not yet able to roll over consistently.

Source page: https://510kreport.com/device/DEN210039
Methodology: https://510kreport.com/methodology