510(k) Report

FDA applicant

Carrington Laboratories, Inc.

Irving, TX15 decisions1989–20020 recalls

FDA records 15 decisions for Carrington Laboratories, Inc. (Irving, TX) from 1989 to 2002: 15 510(k) clearances. Most are in product codes MGQ (Dressing, Wound And Burn, Hydrogel W/Drug…) and OLR (Oral Wound Dressing). Its devices cite 4 predicates, 1 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

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

FDA decisions per year

No FDA decision for Carrington Laboratories, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Carrington Laboratories, 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?

  • MGQDressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic7decisions
  • OLROral Wound Dressing5decisions
  • FRODressing, Wound, Drug3decisions

Whose devices does it build on?

Its devices cite 4 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 38 times; 1 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.

  • K022670Carraklenz and UltraklenzCarrington Laboratories, Inc. · 20029cite it
  • K902345Carrington Wound DressingCarrington Laboratories, Inc. · 19904cite it
  • K964852Radiacare Oral Wound RinseCarrington Laboratories, Inc. · 19974cite it
  • K961758Carasyn Hydrogel Wound ProductsCarrington Laboratories, Inc. · 19963cite it
  • K012126The Salicept Oral PatchCarrington Laboratories, Inc. · 20013cite it
  • K894541Carrington Dermal Wound GelCarrington Laboratories, Inc. · 19893cite it

What has FDA decided for it lately?

  • K022670Carraklenz and UltraklenzCarrington Laboratories, Inc. · 2002
  • K012126The Salicept Oral PatchCarrington Laboratories, Inc. · 2001
  • K983182Aloe Therapy Oral RinseCarrington Laboratories, Inc. · 1998
  • K964852Radiacare Oral Wound RinseCarrington Laboratories, Inc. · 1997
  • K962218Carrasyn Hydrogel Wound Dressing,Carragauze Pads,Carragauze Strips,Carrasorb M FDGCarrington Laboratories, Inc. · 1996
  • K961758Carasyn Hydrogel Wound ProductsCarrington Laboratories, Inc. · 1996
  • K960428Carrasyn Hydrogel Wound Dressing/FDG Pads/Caragauze Strips/Pads (Modification)Carrington Laboratories, Inc. · 1996
  • K953423Casrrasyn Oral Wound DressingCarrington Laboratories, Inc. · 1995

All 15 as Carrington Laboratories, Inc. →