510(k) Report

FDA applicant

Z-Medica Corporation

Wallingford, CT14 decisions2005–20223 recalls

FDA records 14 decisions for Z-Medica Corporation (Wallingford, CT) from 2005 to 2022: 13 510(k) clearances and 1 De Novo grant. Most are in product codes QSY (Hemostatic Wound Dressing Without Thrombin Or…) and POD (Temporary, Internal Use Hemostatic). Its devices cite 21 predicates, 9 of them its own earlier devices. 3 recalls are linked to its devices.

FDA’s records also spell it “Z-Medica, LLC”.

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

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Z-Medica Corporation’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2007: 22008: 12009: 12013: 22014: 12017: 12018: 12020: 12022: 1
2007high 2 (2007) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

1in 2021

2017: 22021: 1
2007high 2 (2017) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Z-Medica Corporation by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Z-Medica Corporation’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?

  • QSYHemostatic Wound Dressing Without Thrombin Or Other Biologics10decisions
  • PODTemporary, Internal Use Hemostatic3decisions
  • LYASplint, Intranasal Septal1decision

Whose devices does it build on?

Its devices cite 21 predicates; 9 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 26 times; 9 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.

  • K072474Quikclot EXZ-Medica Corporation · 20078cite it
  • K051955Quickclot Acs - Accelerated Clotting SpongeZ-Medica Corporation · 20053cite it
  • K123387Quikclot Hemostatic DressingZ-Medica, LLC · 20133cite it
  • K070010Quikclot Sport and Quikclot Sport SilverZ-Medica Corporation · 20072cite it
  • K090620Quikclot Inteventional, Model P/N 182Z-Medica Corporation · 20092cite it
  • K200167QuikClot Control+Z-Medica, LLC · 20202cite it

What has FDA decided for it lately?

  • K220971QuikClot Control+ Hemostatic DressingZ-Medica, LLC · 2022
  • K200167QuikClot Control+Z-Medica, LLC · 2020
  • K181641QuikClot RadialZ-Medica, LLC · 2018
  • DEN160012D2 DressingZ-Medica, LLC · 2017
  • K140757D2 Hemostantic DressingZ-Medica, LLC · 2014
  • K123387Quikclot Hemostatic DressingZ-Medica, LLC · 20132 recalls
  • K120782Interventional Hemostatic BandageZ-Medica Corporation · 2013
  • K090620Quikclot Inteventional, Model P/N 182Z-Medica Corporation · 2009

All 8 as Z-Medica Corporation →All 6 as Z-Medica, LLC →

What has been recalled?

3 recalls linked to its devices; the latest:

  • K072474QuikClot Combat Gauze-For Temporary External Use To Control Traumatic Bleeding Model /…Sep 22, 2021Class II
  • K123387QuikClot TraumaPad, Part# 460 a topical dressing for local management of bleeding wounds…Nov 17, 2017Class II
  • K123387QuikClot TraumaPad, , sterile, soft, white, X-ray detectable hemostatic dressing Part…May 17, 2017Class II