Company · US

Koios Medical, Inc.

FDA 510(k) clearances and medical device recalls filed under this name, 2019 to 2026. Name variants (Inc, Corp, punctuation) are merged.

4510(k) clearances (1 in 12 months)

1recalls (0 in 12 months)

1recalls that name a 510(k)

Product codes

Code	Device	Records
POK	Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer	4
LLZ	System, Image Processing, Radiological	1

Decided	510(k)	Device and applicant	Code
Jul 2, 2026	K253884	Koios DS (3.8) Koios Medical, Inc.	POK
Nov 15, 2024	K242130	Koios DS Koios Medical, Inc.	POK
Dec 16, 2021	K212616	Koios DS Koios Medical, Inc.	POK
Jul 3, 2019	K190442	Koios DS for Breast Koios Medical, Inc.	POK

Date	Firm and product	Code	Linked 510(k)
Dec 31, 2019	Koios Medical, Inc. Koios DS Breast . The device is a software application which assists skilled physicians in analyzing breast ultrasound images. Terminated	LLZ	K161959