# Owlet Babycare, Inc.

- Location (FDA's records): Lehi, UT
- FDA decisions: 2 (2023–2023): 1 510(k) clearance and 1 De Novo grant
- Product codes: DQA (1), QYU (1)
- Predicates its devices cite: 1 (0 its own); citations of its devices by later devices: 1 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Taiwan Aulisa Medical Devices Technologies, Inc.: 1 (https://510kreport.com/company/taiwan-aulisa-medical-devices-technologies)

## Firms that cite its devices most
- Masimo Corporation: 1 (https://510kreport.com/company/masimo)

## Its most-cited devices
- DEN220091: Dream Sock (2023), cited by 1

## Recent decisions
- DEN220091: Dream Sock (Nov 8, 2023)
- K222597: BabySat 3 (Jun 16, 2023)

Source page: https://510kreport.com/company/owlet-babycare