Data / Medical devices / Canada / Kane Biotech Inc
Kane Biotech Inc: FDA-registered device maker in Winnipeg Manitoba, Canada, 2 510(k) clearances
Kane Biotech Inc is registered with the FDA (registration 3009461428) in Winnipeg Manitoba, Canada. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated January 8, 2026. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3009461428
- Address
- Innovation Drive, Winnipeg Manitoba, Canada, R3T 6C5
- Owner or operator
- Kane Biotech Inc (10088724)
- Roles
- Manufacturer, Specification developer
- First device listed
- January 8, 2025
- Registered through
- 2026
- Brand names listed
- revyve antimicrobial skin and wound cleanser, revyve® Antimicrobial Wound Gel, revyve® Antimicrobial Wound Gel (1oz), revyve® Antimicrobial Wound Gel (3oz), revyve® Antimicrobial Wound Gel Spray (5oz)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dressing, Wound, Drug | FRO | U | Manufacturer, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 8, 2026 | K252759 | revyve® Antimicrobial Skin and Wound Cleanser | FRO | Substantially Equivalent | Kane Biotech, Inc. | accessdata.fda.gov |
| July 19, 2024 | K241809 | coactiv+ Antimicrobial Wound Gel | FRO | Substantially Equivalent | Kane Biotech, Inc. | accessdata.fda.gov |
Compare with other makers
Updated January 8, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.