DeviceSignal · 510(k) cleared
Bluewind Medical , Ltd.
FDA 510(k) decision recorded 2026-07-28 · K253651 · Traditional 510(k)
Event510(k) cleared
Effective2026-07-28
DecisionSESE
On 2026-07-28 the FDA recorded a 510(k) clearance decision for Bluewind Medical , Ltd., for Revi System. Clearance K253651. Product code QXM. A clearance is a regulatory decision, not an endorsement of the device.
Reported facts
- 510(k) number
- K253651
- Applicant
- Bluewind Medical , Ltd.
- Device
- Revi System
- Decided on
- 2026-07-28
- Received on
- 2025-11-20
- Decision
- SESE
- Clearance type
- Traditional
- Product code
- QXM
- Review days
- 250
Every field above is as fda_device_510k published it. Nothing on this page is our interpretation.
Provenance
- Source
- fda_device_510k
- Source record
K253651- Snapshot hash
a17b676375c92ad46cfd0c81b2c18852150764f05c544c0889e193548d652e00- Source URL
- https://download.open.fda.gov/device/510k/device-510k-0001-of-0001.json.zip
- Observed
- 2026-09-08T16:22:09.483Z
- Transform
fda_device_510k_to_clearance v1- Event rule
fda_device_510k_cleared v1- Event key
548636cdd815ef985e93ffbeb7b4c9ad614b2bf46244dfe3f2aef0eb355550fc- Signal type
device_clearance.granted
Source terms that apply
- This is not a public alerting service and must not be used to notify patients or the public
- We do not report whether a recall is still open; FDA does not maintain that after classification
- Nothing here is a medical or clinical decision aid
- Not affiliated with, endorsed by, or certified by the FDA
Data provided by the U.S. Food and Drug Administration (https://open.fda.gov)