# Ots Medical, Ltd.

- Location (FDA's records): Tel Aviv, IL
- FDA decisions: 3 (2023–2025): 3 510(k) clearances
- Product codes: MBI (3)
- 510(k) review time since 2016: median 85 days, against 58 for FDA's reviews in the same codes and years (0 of 3 faster)
- Predicates its devices cite: 6 (2 its own); citations of its devices by later devices: 2 (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
- Conmed Corporation: 2 (https://510kreport.com/company/conmed)
- Cayenne Medical, Inc.: 1 (https://510kreport.com/company/cayenne-medical)
- Biomet, Inc.: 1 (https://510kreport.com/company/biomet)

## Its most-cited devices
- K241234: OTS 25-L (100-5) (2025), cited by 1
- K233429: OTS 25 (100-1) (2023), cited by 1

## Recent decisions
- K251310: OTS 25-L (100-5) (Jul 22, 2025)
- K241234: OTS 25-L (100-5) (Jan 23, 2025)
- K233429: OTS 25 (100-1) (Dec 7, 2023)

Source page: https://510kreport.com/company/ots-medical