510(k) · Cleared
ClearedRevi System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bluewind Medical, Ltd. · QXM Implanted Tibial Electrical Urinary Continence Device
Cleared on Dec 12, 2025 as substantially equivalent to K240037 (Bluewind Medical, Ltd., 2024) after a 134-day review. Its family tree reaches back 2 generations to 2023.
- Decided
- Dec 12, 2025
- Review
- 134 days
- Class
- Class II
- Product code
- QXM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN220073 (2023). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QXM? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new QXM device
- #1 K240037 Revi™ Systemscore 13.3 · 1 generation · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K240037 | Revi™ SystemSummary page 5…able tibial electrical urinary continence device (21 CFR 876.5305) V. Classification: Class II VI. Product Code: QXM VII. Predicate Device: Revi System (K240037) Note: The predicate device has not been subject to a design-related recall VIII. Indications for Use The Revi Sys… | 2024 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 2 years and passes through 1 company; a new generation was cleared every 1.6 years on median.
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K240037.
How does its category compare?
All QXM devicesQXM Implanted Tibial Electrical Urinary Continence Device: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · QXM
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QXM
Too few QXM 510(k)s in any year since 2007 to give a median.
Recalls per year · QXM
No recall names QXM since 2007.
Adverse event reports per year · QXM
17in 2025
MAUDE reports naming product code QXM, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 4 |
| 2025 | 1 | — | 0 | 17 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Revi System is indicated for the treatment of patients with symptoms of urgency incontinence alone or in combination with urinary urgency.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252391 · printed Nov 4, 2026
Cite this page
510(k) Report. “K252391: Revi System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K252391
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026