510(k) Report

FDA applicant

Mcgrath Pharmaceuticals, Inc.

Grayslake, IL1 decision2008–20080 recalls

FDA records 1 decision for Mcgrath Pharmaceuticals, Inc. (Grayslake, IL) in 2008: 1 510(k) clearance. All are in product code OLR (Oral Wound Dressing). 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

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

FDA decisions per year

1in 2008

2008: 1
2008high 1 (2008) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2008.

FIG. 1 — Mcgrath Pharmaceuticals, Inc. by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • OLROral Wound Dressing1decision

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 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.

  • K082856Carapaste Oral Wound DressingMcgrath Pharmaceuticals, Inc. · 20081cites it

What has FDA decided for it lately?

  • K082856Carapaste Oral Wound DressingMcgrath Pharmaceuticals, Inc. · 2008

The one decision as Mcgrath Pharmaceuticals, Inc. →

Other applicant names beginning “Mcgrath”

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

Mcgrath Surgical, Ltd. 1