# Oniris

- Location (FDA's records): Rueil Malmaison, FR
- FDA decisions: 2 (2016–2025): 2 510(k) clearances
- Names in FDA's records: Oniris (1); Sas Oniris (1)
- Product codes: LRK (2)
- Predicates its devices cite: 2 (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

## Firms whose devices it cites most
- Smartguard Rx, Inc.: 1 (https://510kreport.com/company/smartguard-rx)
- Tomed Dr. Toussaint GmbH: 1 (https://510kreport.com/company/tomed-dr-toussaint)

## Recent decisions
- K250353: Oniris; Oniris Plus (Sep 4, 2025)
- K150566: Oniris (Mar 21, 2016)

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