# Koios Medical, Inc.

- Location (FDA's records): New York, NY
- FDA decisions: 4 (2019–2026): 4 510(k) clearances
- Product codes: POK (4)
- Predicates its devices cite: 5 (3 its own); citations of its devices by later devices: 5 (3 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Quantitative Insights, Inc.: 1 (https://510kreport.com/company/quantitative-insights)
- Clearview Diagnostics, Inc.: 1 (https://510kreport.com/company/clearview-diagnostics)

## Firms that cite its devices most
- Ultromics Limited: 1 (https://510kreport.com/company/ultromics)
- Sonio: 1 (https://510kreport.com/company/sonio)

## Its most-cited devices
- K190442: Koios DS for Breast (2019), cited by 2
- K212616: Koios DS (2021), cited by 2
- K242130: Koios DS (2024), cited by 1

## Recent decisions
- K253884: Koios DS (3.8) (Jul 2, 2026)
- K242130: Koios DS (Nov 15, 2024)
- K212616: Koios DS (Dec 16, 2021)
- K190442: Koios DS for Breast (Jul 3, 2019)

Source page: https://510kreport.com/company/koios-medical