# Bionica, Inc.

- Location (FDA's records): Laguna Niguel, CA
- FDA decisions: 3 (1987–1989): 3 510(k) clearances
- Product codes: FRN (3)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Recent decisions
- K895426: Ambulatory Infusion Pump (Dec 27, 1989)
- K875316: Bionica MDS 110 Pca (May 11, 1988)
- K864276: Personal Infusion Pump (Mar 17, 1987)

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