510(k) Report

FDA applicant

Anexa Biomedical, Inc.

Zephyrhills, FL2 decisions2016–20170 recalls

FDA records 2 decisions for Anexa Biomedical, Inc. (Zephyrhills, FL) from 2016 to 2017: 2 510(k) clearances. All are in product code FRO (Dressing, Wound, Drug). 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 Anexa Biomedical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

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

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2016.

FIG. 1 — Anexa Biomedical, Inc. 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?

  • FRODressing, Wound, Drug2decisions

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.

  • K172486Anexa Wound Flush, USP Sterile Water, and USP Sterile Normal Saline (0.9% sodium chloride) 120 mL cup, USP…Anexa Biomedical, Inc. · 20171cites it

What has FDA decided for it lately?

  • K172486Anexa Wound Flush, USP Sterile Water, and USP Sterile Normal Saline (0.9% sodium chloride) 120 mL cup, USP…Anexa Biomedical, Inc. · 2017
  • K161658Anexa Wound Flush, Sterile Water & Sterile Normal SalineAnexa Biomedical, Inc. · 2016

All 2 as Anexa Biomedical, Inc. →