510(k) Report

FDA applicant

Belcher Pharmaceuticals, Inc.

Largo, FL1 decision2004–20041 recall

FDA records 1 decision for Belcher Pharmaceuticals, Inc. (Largo, FL) in 2004: 1 510(k) clearance. All are in product code OLR (Oral Wound Dressing). Its devices cite 2 predicates, 0 of them its own earlier devices. 1 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 Belcher Pharmaceuticals, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

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

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Belcher 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?

  • OLROral Wound Dressing1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K042400Mucotrol Concentrated Oral Gel WaferBelcher Pharmaceuticals, Inc. · 20041 recall

The one decision as Belcher Pharmaceuticals, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K042400Product is Mucotrol Concentrated Oral Gel Wafer contained in HDPE Bottle.Sep 25, 2006