510(k) Report

FDA applicant

Koios Medical, Inc.

New York, NY4 decisions2019–20260 recalls

FDA records 4 decisions for Koios Medical, Inc. (New York, NY) from 2019 to 2026: 4 510(k) clearances. All are in product code POK (Computer-Assisted Diagnostic Software For…). Its devices cite 5 predicates, 3 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, radiology panel, where it files most

How often FDA has decided Koios Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2019: 12021: 12024: 12026 (partial year): 1
2019high 1 (2019) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2019.

FIG. 1 — Koios Medical, Inc. by year, 2019–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Koios Medical, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • POKComputer-Assisted Diagnostic Software For Lesions Suspicious For Cancer4decisions

Whose devices does it build on?

Its devices cite 5 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 times; 3 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K190442Koios DS for BreastKoios Medical, Inc. · 20192cite it
  • K212616Koios DSKoios Medical, Inc. · 20212cite it
  • K242130Koios DSKoios Medical, Inc. · 20241cites it

What has FDA decided for it lately?

  • K253884Koios DS (3.8)Koios Medical, Inc. · 2026
  • K242130Koios DSKoios Medical, Inc. · 2024
  • K212616Koios DSKoios Medical, Inc. · 2021
  • K190442Koios DS for BreastKoios Medical, Inc. · 2019

All 4 as Koios Medical, Inc. →