Bluewind Medical , Ltd.: FDA filings under this applicant name
FDA lists 3 510(k) clearances under the applicant name “Bluewind Medical , Ltd.” (first 2024, latest 2026), plus 1 De Novo decision, across 1 product code in 1 review panel. Median 510(k) review time under this name: 134 days. Since 2017 the median was 134 days, against 134 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2024 | 1 | 118 |
| 2025 | 1 | 134 |
| 2026 | 1 | 250 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Bluewind Medical , Ltd. took a median 134 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 134 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| QXM | Implanted Tibial Electrical Urinary Continence Device | 4 | 3 |
Review panels
Most recent Bluewind Medical , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253651 | Revi System | QXM | 2026-07-28 | 250 |
| K252391 | Revi System | QXM | 2025-12-12 | 134 |
| K240037 | Revi System | QXM | 2024-05-02 | 118 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN220073 | De Novo | Implanted Tibial Electrical Urinary Continence Device | 2023-08-16 |
Recalls
openFDA lists no recalls under a recalling firm named Bluewind Medical , Ltd..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Bluewind Medical , Ltd. is the lead sponsor of 6 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:
- NCT06217328: RESTORE: An RCT to Evaluate the Efficacy of the Revi System (Active not recruiting, started 2024-02-24)
- NCT03596671: BlueWind RENOVA iStim™ System for the Treatment of OAB (Completed, started 2019-06-12)
- NCT02777216: ConfidenHT System for Diagnostic Electrical Mapping of Renal Nerves (Completed, started 2016-10)
- NCT02299544: BlueWind Medical System for the Treatment of Patients With OAB (Completed, started 2015-02)
- NCT02209896: BlueWind Reprieve System for the Treatment of PNP (Completed, started 2014-12)
Frequently asked questions
How many FDA 510(k) clearances are listed under Bluewind Medical , Ltd.?
FDA lists 3 510(k) clearances under the applicant name “Bluewind Medical , Ltd.” (first 2024, latest 2026), plus 1 De Novo decision, across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Bluewind Medical , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Bluewind Medical , Ltd. is 134 days. Since 2017: 134 days, versus 134 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Bluewind Medical , Ltd.?
The most frequent FDA product codes under this applicant name are QXM (Implanted Tibial Electrical Urinary Continence Device, 4).
Next steps
- See all 3 Bluewind Medical , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code QXM, Bluewind Medical , Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.