Facility

Koios Medical, Inc.

1 recall(s) on record — most severe on record: Class II.

Key facts

1recalls · worst Class II

1inspections · worst VAI

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3010119782
Establishment type	Manufacture Medical Device
Location	242 West 38th Street New York, NY, US 10018
Registration status	Active · expires 2026
Parent company	Koios Medical, Inc. (owner-operator 10054621)
Brand names	Koios DS

Activity by year

Recalls (1)
Inspections (1)

Devices registered here (2)

Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer
Product code POK (opens in a new tab) · Class II · Radiology · 21 CFR 892.2060
Automated Radiological Image Processing Software
Product code QIH (opens in a new tab) · Class II · Radiology · 21 CFR 892.2050

Recalls & enforcement

Class IITerminated2019-12-31
Affected software product versions were found during internal audit to have been marketed for sale without sufficient documentation pertaining to certain required quality procedures.

FDA inspections (1)

VAI2021-05-13
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

All facilities operated by Koios Medical, Inc.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Koios Medical, Inc. (FEI 3010119782) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3010119782-koios-medical-inc/

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