De Novo · Granted
GrantedRevi 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
Granted on Aug 16, 2023 as a new device type through De Novo after a 315-day review. 3 later devices descend from it.
- Decided
- Aug 16, 2023
- Review
- 315 days
- Class
- Class II
- Product code
- QXM
- Recalls
- None
3 later devices descend from it, 1 citing it directly.
- This deviceDEN220073 Revi SystemBluewind Medical, Ltd. · 2023
- Descendant · cites it directly · 2 of its ownK240037 Revi™ SystemBluewind Medical, Ltd. · 2024
- Descendant · 2 generations on · 0 of its ownK253651 Revi SystemBluewind Medical, Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK252391 Revi SystemBluewind Medical, Ltd. · 2025
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN220073 | Revi System | Bluewind Medical, Ltd. | 2023 | — |
| +1 | K240037 | Revi™ System | Bluewind Medical, Ltd. | 2024 | — |
| +2 | K253651 | Revi System | Bluewind Medical, Ltd. | 2026 | — |
| +2 | K252391 | Revi System | Bluewind Medical, Ltd. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA De Novo 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
- #3 Held for the reportin the report
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K240037 | Revi™ System | 2024 | 2 |
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?
- Of its descendants, K240037 (Bluewind Medical, Ltd., 2024) has gone furthest, with 2 descendants of its own.
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. 2023, 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/DEN220073 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN220073: Revi System.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN220073
Report an extraction error
Are you the manufacturer?
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