510(k) Report

FDA applicant

Novabay Pharmaceuticals

Emeryville, CA5 decisions2007–20150 recalls

FDA records 5 decisions for Novabay Pharmaceuticals (Emeryville, CA) from 2007 to 2015: 5 510(k) clearances. Most are in product codes FRO (Dressing, Wound, Drug) and KMF (Bandage, Liquid). Its devices cite 10 predicates, 3 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Novabay Pharmaceuticals, Inc.”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general hospital panel, where it files most

How often FDA has decided Novabay Pharmaceuticals’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2007: 12008: 12012: 12013: 12015: 1
2007high 1 (2007) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Novabay Pharmaceuticals by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Novabay Pharmaceuticals’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • FRODressing, Wound, Drug3decisions
  • KMFBandage, Liquid1decision
  • LRXCase, Contact Lens1decision

Whose devices does it build on?

Its devices cite 10 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 8 times; 3 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.

  • K113820Neutrophase Antimicrobial Wound CleanserNovabay Pharmaceuticals · 20125cite it
  • K071056Neutrophase Wound CleanserNovabay Pharmaceuticals · 20071cites it
  • K131542Neutrophase (R) Skin and Wound Cleanser OtcNovabay Pharmaceuticals, Inc. · 20131cites it
  • K081009NeutrophaseNovabay Pharmaceuticals · 20081cites it

What has FDA decided for it lately?

  • K143351iCase Contact Lens CaseNovabay Pharmaceuticals, Inc. · 2015
  • K131542Neutrophase (R) Skin and Wound Cleanser OtcNovabay Pharmaceuticals, Inc. · 2013
  • K113820Neutrophase Antimicrobial Wound CleanserNovabay Pharmaceuticals · 2012
  • K081009NeutrophaseNovabay Pharmaceuticals · 2008
  • K071056Neutrophase Wound CleanserNovabay Pharmaceuticals · 2007

All 3 as Novabay Pharmaceuticals →All 2 as Novabay Pharmaceuticals, Inc. →