510(k) · Cleared
ClearedPorcine Dermal Xenografts Porcine Dermal Matrix
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Brennen Medical, LLC · KGN Wound Dressing With Animal-Derived Material (S)
Cleared on Mar 23, 2012 as substantially equivalent to K111436 (Brennen Medical, LLC, 2011) and 2 other predicates after an 84-day review. Its family tree reaches back 11 generations to 1992.
- Decided
- Mar 23, 2012
- Review
- 84 days
- Class
- Class U
- Product code
- KGN
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 11 generations to K921895 (1992). 64 ancestors in all, the oldest K830889 (1983). No later device cites it as a predicate yet.
- Root · 11 generations backK921895 Tissue Patch, Tissue GraftBio-Vascular, Inc. · 1992
- 7 generations between
- 3 generations backK071807 Orthomend Soft Tissue MatrixTei Biosciences, Inc. · 2007 · Recalled
- 2 generations backK081272 Porcine Surgical Mesh; Dermal MatrixBrennen Medical, LLC · 2008 · Recalled
- 1 generation backK111436 Porcine Surgical Mesh, Porcine Dermal MatrixBrennen Medical, LLC · 2011
- This deviceK113866 Porcine Dermal Xenografts Porcine Dermal MatrixBrennen Medical, LLC · 2012
Show all 11 generations
- Root · 11 generations backK921895 Tissue Patch, Tissue GraftBio-Vascular, Inc. · 1992
- 10 generations backK961810 Supple Peri-Guard PericardiumBio-Vascular, Inc. · 1996
- 9 generations backK980431 SurgisisCook Biotech, Inc. · 1998
- 8 generations backK992159 Surgisis SlingCook Biotech, Inc. · 1999
- 7 generations backK001738 Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc. · 2000
- 6 generations backK020049 Fortaflex Surgical MeshOrganogenesis, Inc. · 2002
- 5 generations backK042809 CuffpatchOrganogenesis, Inc. · 2004
- 4 generations backK051766 OrthomendTei Biosciences, Inc. · 2005
- 3 generations backK071807 Orthomend Soft Tissue MatrixTei Biosciences, Inc. · 2007 · Recalled
- 2 generations backK081272 Porcine Surgical Mesh; Dermal MatrixBrennen Medical, LLC · 2008 · Recalled
- 1 generation backK111436 Porcine Surgical Mesh, Porcine Dermal MatrixBrennen Medical, LLC · 2011
- This deviceK113866 Porcine Dermal Xenografts Porcine Dermal MatrixBrennen Medical, LLC · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K921895 | Tissue Patch, Tissue Graft | Bio-Vascular, Inc. | 1992 | — |
| −10 | K961810 | Supple Peri-Guard Pericardium | Bio-Vascular, Inc. | 1996 | — |
| −9 | K980431 | Surgisis | Cook Biotech, Inc. | 1998 | — |
| −8 | K992159 | Surgisis Sling | Cook Biotech, Inc. | 1999 | — |
| −7 | K001738 | Depuy Restore Orthobiologic Soft Tissue Implant | DePuy Orthopaedics, Inc. | 2000 | — |
| −6 | K020049 | Fortaflex Surgical Mesh | Organogenesis, Inc. | 2002 | — |
| −5 | K042809 | Cuffpatch | Organogenesis, Inc. | 2004 | — |
| −4 | K051766 | Orthomend | Tei Biosciences, Inc. | 2005 | — |
| −3 | K071807 | Orthomend Soft Tissue Matrix | Tei Biosciences, Inc. | 2007 | 4 |
| −2 | K081272 | Porcine Surgical Mesh; Dermal Matrix | Brennen Medical, LLC | 2008 | 4 |
| −1 | K111436 | Porcine Surgical Mesh, Porcine Dermal Matrix | Brennen Medical, LLC | 2011 | — |
| 0 (this device) | K113866 | Porcine Dermal Xenografts Porcine Dermal Matrix | Brennen Medical, LLC | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1985 | 1 | 0 |
| 1988 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1996 | 4 | 0 |
| 1997 | 3 | 0 |
| 1998 | 7 | 0 |
| 1999 | 2 | 0 |
| 2000 | 6 | 0 |
| 2001 | 2 | 0 |
| 2002 | 3 | 0 |
| 2003 | 4 | 0 |
| 2004 | 4 | 0 |
| 2005 | 2 | 0 |
| 2006 | 4 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KGN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new KGN device
- #1 K231325 Corplex P / Theracor P / Allacor Pscore 17.9 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K111436 | Porcine Surgical Mesh, Porcine Dermal Matrix | 2011 |
| * | K082103 | LTM Wound DressingSummary page 1…eCleared Brennen Medical Porcine Surgical Mesh KI 11436 10/12/2011 Lifecell's LTM Wound Dressing K082103 10/08/2008 TEI Biosciences PriMatrix K083440 12/12/2008 16.4 DEVICE… | 2008 |
| * | K083440 | Primatrix Dermal Repair ScaffoldSummary page 1…/12/2011 Lifecell's LTM Wound Dressing K082103 10/08/2008 TEI Biosciences PriMatrix K083440 12/12/2008 16.4 DEVICE DESCRIPTION Porcine Dermal Xenograft is an acellular, sterile, porcine dermal xenogra… | 2008 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 20 years and passes through 6 companies; a new generation was cleared every 1.3 years on median.
- 5 of the 64 ancestors have a recall of any class.
How does its category compare?
All KGN devicesKGN Wound Dressing With Animal-Derived Material (S): FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · KGN
15so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · KGN
162in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KGN
3in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KGN
15in 2025
MAUDE reports naming product code KGN, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 3 | 32 | 0 | 0 |
| 2008 | 6 | 87 | 0 | 1 |
| 2009 | 8 | 121 | 0 | 2 |
| 2010 | 4 | 175 | 0 | 3 |
| 2011 | 7 | 228 | 0 | 6 |
| 2012 | 8 | 123 | 0 | 4 |
| 2013 | 6 | 147 | 0 | 6 |
| 2014 | 5 | 188 | 0 | 12 |
| 2015 | 7 | 87 | 0 | 9 |
| 2016 | 4 | 164 | 0 | 6 |
| 2017 | 7 | 136 | 1 | 8 |
| 2018 | 6 | 148 | 3 | 15 |
| 2019 | 3 | 128 | 0 | 11 |
| 2020 | 5 | 279 | 0 | 17 |
| 2021 | 6 | 236 | 0 | 14 |
| 2022 | 12 | 246 | 0 | 13 |
| 2023 | 9 | 194 | 0 | 21 |
| 2024 | 13 | 83 | 0 | 15 |
| 2025 | 10 | 162 | 0 | 15 |
| 2026 | 15 | 174 | 0 | — |
What is it indicated for?
Porcine Dermal Xenograft is intended for the management of wounds that include: Partial and full thickness wounds; Pressure, diabetic, and venous ulcers; Chronic vascular ulcers; Second-degree burns; Surgical wounds-donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence; Trauma wounds-abrasions, lacerations, and skin tears; Tunneled/undermined wounds; Draining wounds. The Porcine Dermal Xenograft provides an environment that supports wound healing and control of minor bleeding. The device is intended for single patient, one time use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113866 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113866: Porcine Dermal Xenografts Porcine Dermal Matrix.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113866
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026