510(k) Report

FDA applicant

Abl Medical, LLC

American Fork, UT2 decisions2014–20160 recalls

FDA records 2 decisions for Abl Medical, LLC (American Fork, UT) from 2014 to 2016: 2 510(k) clearances. All are in product code FRO (Dressing, Wound, Drug). Its devices cite 2 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 Abl Medical, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2016

2014: 12016: 1
2014high 1 (2014) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

FIG. 1 — Abl Medical, LLC by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • FRODressing, Wound, Drug2decisions

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 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.

  • K140483Asap Otc Wound Dressing GelAbl Medical, LLC · 20141cites it

What has FDA decided for it lately?

  • K151185AGRX Wound Wash Antibacterial Silver Skin and Wound Cleanser (Rx) and AGX Wound Wash Skin and Wound Cleanser…Abl Medical, LLC · 2016
  • K140483Asap Otc Wound Dressing GelAbl Medical, LLC · 2014

All 2 as Abl Medical, LLC →