Revi System
FDA 510(k) clearance K252391 · decided 2025-12-12
Clearance details
- K-number
- K252391
- Device name
- Revi System
- Applicant
- Bluewind Medical , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2025-07-31
- Decision date
- 2025-12-12
- Days to decision
- 134 days
- Clearance type
- Traditional
- Product code
- QXM
- Device class
- 2
- Regulation number
- 876.5305
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Herzliya, IL
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Revi System (K253651) | Bluewind Medical , Ltd. | 2026-07-28 |
| Revi™ System (K240037) | Bluewind Medical , Ltd. | 2024-05-02 |
| Revi System (DEN220073) | Bluewind Medical , Ltd. | 2023-08-16 |
Recalls involving this device
No recalls on record reference this clearance.