# Enbio Group AG

- Location (FDA's records): Oensingen, CH
- FDA decisions: 3 (2021–2026): 3 510(k) clearances
- Product codes: FLE (3)
- 510(k) review time since 2016: median 63 days, against 133 for FDA's reviews in the same codes and years (2 of 3 faster)
- Predicates its devices cite: 3 (2 its own); citations of its devices by later devices: 3 (2 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
- Scican, Ltd.: 1 (https://510kreport.com/company/scican)

## Firms that cite its devices most
- Guangzhou Ajax Medical Equipment Co., Ltd.: 1 (https://510kreport.com/company/guangzhou-ajax-medical-equipment)

## Its most-cited devices
- K210279: Enbio S (2021), cited by 2
- K213991: Enbio S (2022), cited by 1

## Recent decisions
- K260254: Enbio PRO (Feb 26, 2026)
- K213991: Enbio S (Feb 22, 2022)
- K210279: Enbio S (Oct 29, 2021)

Source page: https://510kreport.com/company/enbio-group