510(k) Report

FDA applicant

Trigen Laboratories, Inc.

Lake Wiley, SC3 decisions2011–20120 recalls

FDA records 3 decisions for Trigen Laboratories, Inc. (Lake Wiley, SC) from 2011 to 2012: 3 510(k) clearances. All are in product code FRO (Dressing, Wound, Drug). Its devices cite 3 predicates, 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

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

FDA decisions per year

1in 2012

2011: 22012: 1
2011high 2 (2011) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2011.

FIG. 1 — Trigen Laboratories, Inc. by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Trigen 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?

  • FRODressing, Wound, Drug3decisions

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 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.

  • K121134TL Triseb CreamTrigen Laboratories, Inc. · 20121cites it
  • K110757TL-Cermide Skin Barrier EmulsionTrigen Laboratories, Inc. · 20111cites it

What has FDA decided for it lately?

  • K121134TL Triseb CreamTrigen Laboratories, Inc. · 2012
  • K110762Avo Barrier Topical EmulsionTrigen Laboratories, Inc. · 2011
  • K110757TL-Cermide Skin Barrier EmulsionTrigen Laboratories, Inc. · 2011

All 3 as Trigen Laboratories, Inc. →