510(k) Report

FDA applicant

Dpt Laboratories, Ltd.

Fort Worth, TX3 decisions1995–19970 recalls

FDA records 3 decisions for Dpt Laboratories, Ltd. (Fort Worth, TX) from 1995 to 1997: 3 510(k) clearances. Most are in product codes MGQ (Dressing, Wound And Burn, Hydrogel W/Drug…) and KMF (Bandage, Liquid). Its devices cite 1 predicate, 0 of them its own earlier devices. 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 Dpt Laboratories, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Dpt Laboratories, Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Dpt Laboratories, Ltd. 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?

  • MGQDressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic2decisions
  • KMFBandage, Liquid1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 8 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.

  • K965120Allclenz Wound CleanserDpt Laboratories, Ltd. · 19978cite it

What has FDA decided for it lately?

  • K965120Allclenz Wound CleanserDpt Laboratories, Ltd. · 1997
  • K953816Dcurasol Gel Wound DressingDpt Laboratories, Ltd. · 1995
  • K953450Curasol Gel Wound DressingDpt Laboratories, Ltd. · 1995

All 3 as Dpt Laboratories, Ltd. →