510(k) Report

FDA applicant

Dermacare

Louisville, KY3 decisions1988–20061 recall

FDA records 3 decisions for Dermacare (Louisville, KY) from 1988 to 2006: 3 510(k) clearances. Most are in product codes GEI (Electrosurgical, Cutting & Coagulation &…) and KGS (Retention Device, Suture). Its devices cite 2 predicates, 0 of them its own earlier devices. 1 recall is linked to its devices.

FDA’s records also spell it “Dermacare, Inc.”.

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 Dermacare’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Dermacare since 2007.

Recalls per year

1in 2012

2012: 1
2007high 1 (2012) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Dermacare’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?

  • GEIElectrosurgical, Cutting & Coagulation & Accessories1decision
  • KGSRetention Device, Suture1decision
  • GEXPowered Laser Surgical Instrument1decision

Whose devices does it build on?

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

Who builds on its devices?

Later devices cite its devices 7 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.

  • K060653ThermaclearDermacare, Inc. · 20065cite it
  • K884656Disposable Bipolar Cord and Bipolar ForcepDermacare · 19882cite it

What has FDA decided for it lately?

  • K060653ThermaclearDermacare, Inc. · 2006
  • K893995Dermacare Tie HolderDermacare · 1989
  • K884656Disposable Bipolar Cord and Bipolar ForcepDermacare · 19881 recall

All 2 as Dermacare →The one decision as Dermacare, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K884656Bayonet Forceps 7.-1/8 (181.0mm) 0.75mm Insulated Tips, Sterile Single Use…Jun 1, 2012Class II

Other applicant names beginning “Dermacare”

FDA records each applicant name separately; these may or may not be the same firm.

Dermacare Products, Inc. 8