Data / Medical devices / United States / Koios Medical, Inc.
Koios Medical, Inc.: FDA-registered device maker in New York, NY, United States, 4 510(k) clearances
Koios Medical, Inc. is registered with the FDA (registration 3010119782) in New York, NY, United States. It lists 3 device types. The FDA files 4 510(k) clearances under its listings, the newest dated July 2, 2026. 1 recall event names it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3010119782
- Address
- 242 West 38th Street 14th Floor, New York, NY, United States, 10018
- Owner or operator
- Koios Medical, Inc. (10054621)
- Roles
- Manufacturer
- First device listed
- October 3, 2019
- Registered through
- 2027
- Brand names listed
- Koios DS, Koios DS Breast
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Automated Radiological Image Processing Software | QIH | 2 | Manufacturer | accessdata.fda.gov |
| Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer | POK | 2 | Manufacturer | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 2 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| July 2, 2026 | K253884 | Koios DS (3.8) | POK | Substantially Equivalent | Koios Medical, Inc. | accessdata.fda.gov |
| November 15, 2024 | K242130 | Koios DS | POK | Substantially Equivalent | Koios Medical, Inc. | accessdata.fda.gov |
| December 16, 2021 | K212616 | Koios DS | POK | Substantially Equivalent | Koios Medical, Inc. | accessdata.fda.gov |
| July 3, 2019 | K190442 | Koios DS for Breast | POK | Substantially Equivalent | Koios Medical, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| December 31, 2019 | 84615 | Class II | Terminated | Koios DS Breast. The device is a software application which assists skilled physicians in analyzing breast ultrasound images. | Affected software product versions were found during internal audit to have been marketed for sale without sufficient documentation pertaining to certain required quality procedures. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Image Processing, Radiological
- All makers of Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer
- All makers of Automated Radiological Image Processing Software
Updated July 2, 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.