# Bluewind Medical, Ltd.

- Location (FDA's records): Herzliya, IL
- FDA decisions: 4 (2023–2026): 3 510(k) clearances and 1 De Novo grant
- Product codes: QXM (4)
- Predicates its devices cite: 3 (3 its own); citations of its devices by later devices: 3 (3 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Its most-cited devices
- K240037: Revi™ System (2024), cited by 2
- DEN220073: Revi System (2023), cited by 1

## Recent decisions
- K253651: Revi System (Jul 28, 2026)
- K252391: Revi System (Dec 12, 2025)
- K240037: Revi™ System (May 2, 2024)
- DEN220073: Revi System (Aug 16, 2023)

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