Data / Medical devices / United States / Kairos Biosciences
Kairos Biosciences: FDA-registered device maker in Millcreek, UT, United States, 2 510(k) clearances
Kairos Biosciences is registered with the FDA (registration 3039169663) in Millcreek, UT, United States. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated April 5, 2023. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3039169663
- Address
- 1053 E 3300 S #2238, Millcreek, UT, United States, 84106
- Owner or operator
- Kairos Biosciences (10093733)
- Roles
- Complaint file establishment, Repackager or relabeler
- First device listed
- June 30, 2025
- Registered through
- 2027
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dressing, Wound, Drug | FRO | U | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Wound Dressing With Animal-Derived Material(S) | KGN | U | Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| April 5, 2023 | K223310 | Antimicrobial Silicone PHMB Foam Wound Dressing | FRO | Substantially Equivalent | Advanced Medical Solutions Limited | accessdata.fda.gov |
| October 24, 2001 | K012990 | COLLATEK POWDER | KGN | Substantially Equivalent | Biocore Medical Technologies, Inc. | accessdata.fda.gov |
Compare with other makers
Updated April 5, 2023. 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.