510(k) Report

FDA applicant

Woodroof Laboratories, Inc.

Mchenry, IL2 decisions1979–19850 recalls

FDA records 2 decisions for Woodroof Laboratories, Inc. (Mchenry, IL) from 1979 to 1985: 2 510(k) clearances. All are in product code KGN (Wound Dressing With Animal-Derived Material (S)). 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 Woodroof Laboratories, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

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

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Woodroof Laboratories, Inc. 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?

  • KGNWound Dressing With Animal-Derived Material (S)1decision

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K790496Biobrane Brand Temporary Wound DressingWoodroof Laboratories, Inc. · 19791cites it

What has FDA decided for it lately?

  • K844052Biobrane Brand Temp. Wound Dressing W/AdhesiveWoodroof Laboratories, Inc. · 1985
  • K790496Biobrane Brand Temporary Wound DressingWoodroof Laboratories, Inc. · 1979

All 2 as Woodroof Laboratories, Inc. →

Other applicant names beginning “Woodroof”

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

Woodroof Mfg., Inc. 1