510(k) Report

FDA applicant

Strukmyer Medical, LLC

Mesquite, TX3 decisions2016–20231 recall

FDA records 3 decisions for Strukmyer Medical, LLC (Mesquite, TX) from 2016 to 2023: 3 510(k) clearances. Most are in product codes KGN (Wound Dressing With Animal-Derived Material (S)) and FRO (Dressing, Wound, Drug). Since 2016 its 510(k)s took a median of 84 days from receipt to decision, against 194 for FDA’s reviews in the same codes and years. Its devices cite 3 predicates, 0 of them its own earlier devices. 1 recall is linked to its devices.

FDA’s records also spell it “Strukmyer Medical”.

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

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

FDA decisions per year

1in 2023

2016: 12017: 12023: 1
2016high 1 (2016) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

1in 2022

2022: 1
2016high 1 (2022) · low 0 (2016)2026

Class I Class II/III not classified

FIG. 1 — Strukmyer Medical, LLC by year, 2016–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • KGNWound Dressing With Animal-Derived Material (S)2decisions
  • FRODressing, Wound, Drug1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 84 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 194 days; 3 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 times; 0 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.

  • K171645CoMatryx Collagen Wound Dressing 1 gram pouch, CoMatryx Collagen Wound Dressing 1 gram vial, CoMatryx…Strukmyer Medical · 20173cite it
  • K161311USP Sterile Water, 120 mL cup, USP Sterile Normal Saline (0.9% sodium chloride), 120 mL cup, USP Sterile…Strukmyer Medical, LLC · 20161cites it

What has FDA decided for it lately?

  • K232758Comatryx OTCStrukmyer Medical, LLC · 2023
  • K171645CoMatryx Collagen Wound Dressing 1 gram pouch, CoMatryx Collagen Wound Dressing 1 gram vial, CoMatryx…Strukmyer Medical · 20171 recall
  • K161311USP Sterile Water, 120 mL cup, USP Sterile Normal Saline (0.9% sodium chloride), 120 mL cup, USP Sterile…Strukmyer Medical, LLC · 2016

All 2 as Strukmyer Medical, LLC →The one decision as Strukmyer Medical →

What has been recalled?

1 recall linked to its devices; the latest:

  • K171645DERMARITE INDUSTRIES DermaCol 100 Collagen Powder DermaCol 100 Collagen 1 Gram Model…May 25, 2022Class III