510(k) Report

FDA applicant

Fountain Pharmaceuticals, Inc.

Knoxville, TN2 decisions1990–19910 recalls

FDA records 2 decisions for Fountain Pharmaceuticals, Inc. (Knoxville, TN) from 1990 to 1991: 2 510(k) clearances. Most are in product codes NAD (Dressing, Wound, Occlusive) and KOZ (Beads, Hydrophilic, For Wound Exudate Absorption). 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 and plastic surgery panel, where it files most

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

FDA decisions per year

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

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Fountain 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?

  • NADDressing, Wound, Occlusive1decision
  • KOZBeads, Hydrophilic, For Wound Exudate Absorption1decision

What has FDA decided for it lately?

  • K904604Redi-Release Absorbent DressingFountain Pharmaceuticals, Inc. · 1991
  • K895654Sorbex (TM) Soft SpongeFountain Pharmaceuticals, Inc. · 1990

All 2 as Fountain Pharmaceuticals, Inc. →