510(k) Report

FDA applicant

Oclassen Pharmaceuticals, Inc.

San Rafael, CA1 decision1994–19940 recalls

FDA records 1 decision for Oclassen Pharmaceuticals, Inc. (San Rafael, CA) in 1994: 1 510(k) clearance. All are in product code KMF (Bandage, Liquid). No 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 hospital panel, where it files most

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

FDA decisions per year

No FDA decision for Oclassen Pharmaceuticals, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • KMFBandage, Liquid1decision

Who builds on its devices?

Later devices cite its devices 3 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.

  • K940414Iodoflex PasteOclassen Pharmaceuticals, Inc. · 19943cite it

What has FDA decided for it lately?

  • K940414Iodoflex PasteOclassen Pharmaceuticals, Inc. · 1994

The one decision as Oclassen Pharmaceuticals, Inc. →