# K252391: Revi System

- Pathway: 510(k) (Traditional)
- Applicant: Bluewind Medical, Ltd.
- Decided: Dec 12, 2025 after 134 days
- Product code: QXM (Implanted Tibial Electrical Urinary Continence Device)
- Device class: 2
- Regulation: 21 CFR 876.5305
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to DEN220073 (2023). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K240037: Revi™ System, Bluewind Medical, Ltd. (2024) Summary page 5.

## Indications for use
The Revi System is indicated for the treatment of patients with symptoms of urgency incontinence alone or in combination with urinary urgency.

Source page: https://510kreport.com/device/K252391
Methodology: https://510kreport.com/methodology