510(k) Report

FDA applicant

Dermaco, Inc.

Denver, CO1 decision1992–19920 recalls

FDA records 1 decision for Dermaco, Inc. (Denver, CO) in 1992: 1 510(k) clearance. All are in product code KGX (Tape And Bandage, Adhesive). 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 Dermaco, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Dermaco, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Dermaco, Inc.’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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