Koios Medical, Inc.

New York, NY, US

Koios Medical, Inc. appears in FDA device records in New York, NY. FDA records list 4 510(k) clearances between 2019-07-03 and 2026-07-02, no PMA records and one registered establishment. As of 2026-09-10, FDA records show one recall for this company, and at least one establishment registration is current.

510(k) clearances: 4
PMA records: 0
Recall records: 1
Registered establishments: 1

510(k) clearance history

FDA records hold 4 510(k) clearances for Koios Medical, Inc. between 2019 and 2026. The busiest year on record is 2019, with 1. The most recent is 2026, with 1.

Clearances by year, as a table

510(k) clearance decisions for Koios Medical, Inc., by decision year
Year	Clearances
2019	1
2021	1
2024	1
2026	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K253884	Koios DS (3.8)	POK	Substantially Equivalent	2026-07-02
K242130	Koios DS	POK	Substantially Equivalent	2024-11-15
K212616	Koios DS	POK	Substantially Equivalent	2021-12-16
K190442	Koios DS for Breast	POK	Substantially Equivalent	2019-07-03

Registered establishments

FDA registered establishments for Koios Medical, Inc., with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
3010119782	3010119782	Koios Medical, Inc.	242 West 38th Street, New York, NY 10018 US	2026	LLZ POK QIH

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
Recall	Product	Reason	Classification	Initiated	Status
Z-0820-2020	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.	Class II	2019-12-31	Terminated

Verification record

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain