510(k) Report

FDA applicant

Dermatech Medical, Inc.

Castle Rock, CO1 decision2006–20060 recalls

FDA records 1 decision for Dermatech Medical, Inc. (Castle Rock, CO) in 2006: 1 510(k) clearance. All are in product code FPA (Set, Administration, Intravascular). 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 Dermatech Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Dermatech Medical, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Dermatech Medical, 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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Which product codes does it file in?

  • FPASet, Administration, Intravascular1decision

What has FDA decided for it lately?

  • K060488Dermatech IV HolderDermatech Medical, Inc. · 2006

The one decision as Dermatech Medical, Inc. →