510(k) Report

FDA applicant

Brennen Medical, Inc.

St. Paul, MN20 decisions1994–20125 recalls

FDA records 20 decisions for Brennen Medical, Inc. (St. Paul, MN) from 1994 to 2012: 20 510(k) clearances. Most are in product codes MGQ (Dressing, Wound And Burn, Hydrogel W/Drug…) and KGN (Wound Dressing With Animal-Derived Material (S)). Its devices cite 20 predicates, 6 of them its own earlier devices. 5 recalls are linked to its devices.

FDA’s records also spell it “Brennen Medical, LLC”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

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

FDA decisions per year

1in 2012

2008: 12011: 12012: 1
2007high 1 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2019

2011: 42019: 1
2007high 4 (2011) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Brennen Medical, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • MGQDressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic7decisions
  • KGNWound Dressing With Animal-Derived Material (S)4decisions
  • FTMMesh, Surgical2decisions
  • PAGMesh, Surgical, Non-Synthetic, Urogynecologic, For Stress Urinary Incontinence…2decisions
  • MDAElastomer, Silicone, For Scar Management2decisions
  • FRODressing, Wound, Drug1decision

Also: KMF (1), FTL (1).

Whose devices does it build on?

Its devices cite 20 predicates; 6 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 12 times; 6 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.

  • K081272Porcine Surgical Mesh; Dermal MatrixBrennen Medical, LLC · 20083cite it
  • K030460Modification to Brennen Biosynthetic Surgical Mesh MatrixBrennen Medical, Inc. · 20032cite it
  • K982403Brennen Biosynthetic Surgical Mesh MatrixBrennen Medical, Inc. · 19982cite it
  • K964241Brennen Medical Glucan II Wound DressingBrennen Medical, Inc. · 19961cites it
  • K111436Porcine Surgical Mesh, Porcine Dermal MatrixBrennen Medical, LLC · 20111cites it
  • K935060Brennen Medical Sterile Saline SolutionBrennen Medical, Inc. · 19941cites it

What has FDA decided for it lately?

  • K113866Porcine Dermal Xenografts Porcine Dermal MatrixBrennen Medical, LLC · 2012
  • K111436Porcine Surgical Mesh, Porcine Dermal MatrixBrennen Medical, LLC · 2011
  • K081272Porcine Surgical Mesh; Dermal MatrixBrennen Medical, LLC · 20084 recalls
  • K050086Brennen Medical Silver Glucan Wound DressingBrennen Medical, Inc. · 2006
  • K030460Modification to Brennen Biosynthetic Surgical Mesh MatrixBrennen Medical, Inc. · 2003
  • K021835Brennen Medical Surgical Mesh, Glucamesh/GlucatexBrennen Medical, Inc. · 2002
  • K002077Glucanpro CreamBrennen Medical, Inc. · 2000
  • K002078Beta Glucan Gel (Macropro Gel)Brennen Medical, Inc. · 2000

All 17 as Brennen Medical, Inc. →All 3 as Brennen Medical, LLC →

What has been recalled?

5 recalls linked to its devices; the latest:

  • K935189EZ Derm Porcine Xenograft, labeled as the following: a. EZ Derm 3x4 (8x10 cm)…Mar 26, 2019Class II
  • K081272XenMatrix Surgical Graft Sterile, Porcine Dermal Matrix 19 x 28 cm Rectangle Catalog #…Jan 7, 2011
  • K081272XenMatrix Surgical Graft Sterile, Porcine Dermal Matrix 10 x 15 cm Rectangle Catalog #…Jan 7, 2011
  • K081272XenMatrix Surgical Graft Sterile, Porcine Dermal Matrix 15 x 20 cm Rectangle Catalog #…Jan 7, 2011
  • K081272XenMatrix Surgical Graft ,Sterile, Porcine Dermal Matrix 19 x 35 cm Rectangle Catalog #…Jan 7, 2011