# K1 Medical, LLC

- Location (FDA's records): Woodbridge, CT
- FDA decisions: 4 (2019–2021): 4 510(k) clearances
- Product codes: KCT (4)
- 510(k) review time since 2016: median 97 days, against 185 for FDA's reviews in the same codes and years (4 of 4 faster)
- Predicates its devices cite: 4 (3 its own); citations of its devices by later devices: 3 (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
- Medtronic Sofamor Danek USA, Inc.: 1 (https://510kreport.com/company/medtronic-sofamor-danek-usa)

## Its most-cited devices
- K192487: EZ-TRAX Containment Device (2019), cited by 1
- K202270: EZ-TRAX Stryker Mako Total Knee with Triathlon Containment Device (2020), cited by 1
- K211007: EZ-TRAXTM Persona Knee Containment Device (2021), cited by 1

## Recent decisions
- K213209: EZ-TRAX Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Device (Dec 28, 2021)
- K211007: EZ-TRAXTM Persona Knee Containment Device (Jul 1, 2021)
- K202270: EZ-TRAX Stryker Mako Total Knee with Triathlon Containment Device (Dec 2, 2020)
- K192487: EZ-TRAX Containment Device (Dec 23, 2019)

Source page: https://510kreport.com/company/k1-medical