510(k) Report

FDA applicant

Traumacure, Inc.

Washington, DC2 decisions2007–20080 recalls

FDA records 2 decisions for Traumacure, Inc. (Washington, DC) from 2007 to 2008: 2 510(k) clearances. All are in product code QSY (Hemostatic Wound Dressing Without Thrombin Or…). Its devices cite 2 predicates, 1 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

How often FDA has decided Traumacure, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2008

2007: 12008: 1
2007high 1 (2007) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Traumacure, Inc.’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 Biologics2decisions

Whose devices does it build on?

Its devices cite 2 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 1 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.

  • K071936Woundstat, Model TC1001Traumacure, Inc. · 20072cite it
  • K081183WoundstatTraumacure, Inc. · 20081cites it

What has FDA decided for it lately?

  • K081183WoundstatTraumacure, Inc. · 2008
  • K071936Woundstat, Model TC1001Traumacure, Inc. · 2007

All 2 as Traumacure, Inc. →