510(k) Report

FDA applicant

Evolution Medical Technologies, LLC

Portland, OR1 decision2009–20090 recalls

FDA records 1 decision for Evolution Medical Technologies, LLC (Portland, OR) in 2009: 1 510(k) clearance. All are in product code QSY (Hemostatic Wound Dressing Without Thrombin Or…). Its devices cite 3 predicates, 0 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 Evolution Medical Technologies, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2009

2009: 1
2009high 1 (2009) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2009.

FIG. 1 — Evolution Medical Technologies, LLC by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • QSYHemostatic Wound Dressing Without Thrombin Or Other Biologics1decision

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 1 time; 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.

  • K091194Algiseal PadEvolution Medical Technologies, LLC · 20091cites it

What has FDA decided for it lately?

  • K091194Algiseal PadEvolution Medical Technologies, LLC · 2009

The one decision as Evolution Medical Technologies, LLC →

Other applicant names beginning “Evolution”

FDA records each applicant name separately; these may or may not be the same firm.

Evolution Spine 14Evolution Devices, Inc. 1Evolution Optiks Limited 1