510(k) Report

FDA applicant

Vomaris Innovations, Inc.

Chandler, AZ2 decisions2013–20160 recalls

FDA records 2 decisions for Vomaris Innovations, Inc. (Chandler, AZ) from 2013 to 2016: 2 510(k) clearances. All are in product code FRO (Dressing, Wound, Drug). Its devices cite 5 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 Vomaris Innovations, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2016

2013: 12016: 1
2013high 1 (2013) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2013.

FIG. 1 — Vomaris Innovations, Inc. by year, 2013–2026Sources: 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 5 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.

  • K130350ProcelleraVomaris Innovations, Inc. · 20132cite it
  • K160783ProcelleraVomaris Innovations, Inc. · 20161cites it

What has FDA decided for it lately?

  • K160783ProcelleraVomaris Innovations, Inc. · 2016
  • K130350ProcelleraVomaris Innovations, Inc. · 2013

All 2 as Vomaris Innovations, Inc. →

Other applicant names beginning “Vomaris”

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

Vomaris Wound Care, Inc. 1