# Baebies, Inc.

- Location (FDA's records): Durham, NC
- FDA decisions: 4 (2017–2026): 3 510(k) clearances and 1 De Novo grant
- Product codes: QOF (2), JBF (1), PQW (1)
- Predicates its devices cite: 3 (1 its own); citations of its devices by later devices: 2 (1 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
- Pointe Scientific, Inc.,: 1 (https://510kreport.com/company/pointe-scientific)
- Diasorin Molecular, LLC: 1 (https://510kreport.com/company/diasorin-molecular)

## Firms that cite its devices most
- Wallac Oy, A Subsidiary of Perkinelmer, Inc.: 1 (https://510kreport.com/company/wallac-oy-a-subsidiary-of-perkinelmer)

## Its most-cited devices
- DEN150035: SEEKER System (2017), cited by 1
- K252269: FINDER Flu A&B/SARS-CoV-2 Test (2026), cited by 1

## Recent decisions
- K261837: FINDER Flu A&B/SARS-CoV-2 Test (Sep 11, 2026)
- K252269: FINDER Flu A&B/SARS-CoV-2 Test (Mar 30, 2026)
- K201049: Finder G6PD (Sep 14, 2022)
- DEN150035: SEEKER System (Feb 3, 2017)

Source page: https://510kreport.com/company/baebies