510(k) Report

FDA applicant

Accuro Medical Products, LLC

Denver, CO1 decision2011–20111 recall

FDA records 1 decision for Accuro Medical Products, LLC (Denver, CO) in 2011: 1 510(k) clearance. All are in product code OMP (Negative Pressure Wound Therapy Powered…). Its devices cite 2 predicates, 0 of them its own earlier devices. 1 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 and plastic surgery panel, where it files most

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

FDA decisions per year

1in 2011

2011: 1
2011high 1 (2011) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

1in 2012

2012: 1
2011high 1 (2012) · low 0 (2011)2026

Class I Class II/III not classified

FIG. 1 — Accuro Medical Products, LLC by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • OMPNegative Pressure Wound Therapy Powered Suction Pump1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 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.

  • K100823Wound Pro ApexAccuro Medical Products, LLC · 20112cite it

What has FDA decided for it lately?

  • K100823Wound Pro ApexAccuro Medical Products, LLC · 20111 recall

The one decision as Accuro Medical Products, LLC →

What has been recalled?

1 recall linked to its devices; the latest:

  • K100823Wound Pro Apex Negative Pressure Wound Therapy Powered Suction Pump; Accuro Medical…Aug 31, 2012Class II

Other applicant names beginning “Accuro”

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

Accuro Technologies, Inc. 1