# K240037: Revi™ System

- Pathway: 510(k) (Traditional)
- Applicant: Bluewind Medical, Ltd.
- Decided: May 2, 2024 after 118 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: 1 generation back to DEN220073 (2023). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN220073: Revi System, Bluewind Medical, Ltd. (2023) Summary page 6.

## Most influential descendants
- K253651: Revi System (2026), 0 descendants of its own
- K252391: Revi System (2025), 0 descendants of its own

## 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/K240037
Methodology: https://510kreport.com/methodology