510(k) Report

FDA applicant

K1 Medical, LLC

Woodbridge, CT4 decisions2019–20210 recalls

FDA records 4 decisions for K1 Medical, LLC (Woodbridge, CT) from 2019 to 2021: 4 510(k) clearances. All are in product code KCT (Sterilization Wrap Containers, Trays…). Since 2016 its 510(k)s took a median of 97 days from receipt to decision, against 185 for FDA’s reviews in the same codes and years. Its devices cite 4 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, general hospital panel, where it files most

How often FDA has decided K1 Medical, LLC’s devices, and how often a recall has named them.

FDA decisions per year

2in 2021

2019: 12020: 12021: 2
2019high 2 (2021) · low 0 (2022)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2019.

FIG. 1 — K1 Medical, LLC by year, 2019–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like K1 Medical, LLC’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?

  • KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories4decisions

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 97 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 185 days; 4 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 4 predicates; 3 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K192487EZ-TRAX Containment DeviceK1 Medical, LLC · 20191cites it
  • K202270EZ-TRAX Stryker Mako Total Knee with Triathlon Containment DeviceK1 Medical, LLC · 20201cites it
  • K211007EZ-TRAXTM Persona Knee Containment DeviceK1 Medical, LLC · 20211cites it

What has FDA decided for it lately?

  • K213209EZ-TRAX Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment DeviceK1 Medical, LLC · 2021
  • K211007EZ-TRAXTM Persona Knee Containment DeviceK1 Medical, LLC · 2021
  • K202270EZ-TRAX Stryker Mako Total Knee with Triathlon Containment DeviceK1 Medical, LLC · 2020
  • K192487EZ-TRAX Containment DeviceK1 Medical, LLC · 2019

All 4 as K1 Medical, LLC →