510(k) · Cleared
ClearedMarigen Wound Dressing
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kerecis Limited · KGN Wound Dressing With Animal-Derived Material (S)
Cleared on Oct 23, 2013 as substantially equivalent to K092096 (Mesynthes, Ltd., 2010) and 6 other predicates after an 85-day review. Its family tree reaches back 7 generations to 1992. 5 later devices descend from it.
- Decided
- Oct 23, 2013
- Review
- 85 days
- Class
- Class U
- Product code
- KGN
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 7 generations to K921895 (1992). 63 ancestors in all, the oldest K830889 (1983). 5 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK921895 Tissue Patch, Tissue GraftBio-Vascular, Inc. · 1992
- 6 generations backK961810 Supple Peri-Guard PericardiumBio-Vascular, Inc. · 1996
- 5 generations backK980431 SurgisisCook Biotech, Inc. · 1998
- 4 generations backK043366 Permacol Surgical ImplantTissue Science Laboratories, Plc · 2004
- 3 generations backK050355 Permacol Surgical Implant T-Piece, Permacol Surgical Implant…Tissue Science Laboratories, Plc · 2005
- 2 generations backK070560 LRTM Surgical MeshLifecell Corp. · 2007 · Recalled
- 1 generation backK082103 LTM Wound DressingLifecell Corp. · 2008
- This deviceK132343 Marigen Wound DressingKerecis Limited · 2013
- Descendant · cites it directly · 3 of its ownK190528 MariGen Wound ExtraKerecis Limited · 2019
- Descendant · 2 generations on · 1 of its ownK241080 Kerecis Parvus (50207)Kerecis Limited · 2024
- Descendant · 2 generations on · 1 of its ownK213231 Kerecis SiliconeKerecis Limited · 2022
- Descendant · 2 generations on · 0 of its ownK251845 Marigen Wound Extra; Kerecis Silicone; Kerecis ParvusKerecis Limited · 2025
- Descendant · cites it directly · 0 of its ownK153364 Kerecis SecureMeshKerecis Limited · 2016
Most influential descendants
Showing 5 of 5 · See all- K190528MariGen Wound ExtraKerecis Limited · 2019 · cites it directly3descendants
- K241080Kerecis Parvus (50207)Kerecis Limited · 2024 · 2 generations on1descendant
- K213231Kerecis SiliconeKerecis Limited · 2022 · 2 generations on1descendant
- K251845Marigen Wound Extra; Kerecis Silicone; Kerecis ParvusKerecis Limited · 2025 · 2 generations on0descendants
- K153364Kerecis SecureMeshKerecis Limited · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K921895 | Tissue Patch, Tissue Graft | Bio-Vascular, Inc. | 1992 | — |
| −6 | K961810 | Supple Peri-Guard Pericardium | Bio-Vascular, Inc. | 1996 | — |
| −5 | K980431 | Surgisis | Cook Biotech, Inc. | 1998 | — |
| −4 | K043366 | Permacol Surgical Implant | Tissue Science Laboratories, Plc | 2004 | — |
| −3 | K050355 | Permacol Surgical Implant T-Piece, Permacol Surgical Implant Rectocele-Piece… | Tissue Science Laboratories, Plc | 2005 | — |
| −2 | K070560 | LRTM Surgical Mesh | Lifecell Corp. | 2007 | 2 |
| −1 | K082103 | LTM Wound Dressing | Lifecell Corp. | 2008 | — |
| 0 (this device) | K132343 | Marigen Wound Dressing | Kerecis Limited | 2013 | — |
| +1 | K190528 | MariGen Wound Extra | Kerecis Limited | 2019 | — |
| +2 | K241080 | Kerecis Parvus (50207) | Kerecis Limited | 2024 | — |
| +2 | K213231 | Kerecis Silicone | Kerecis Limited | 2022 | — |
| +2 | K251845 | Marigen Wound Extra; Kerecis Silicone; Kerecis Parvus | Kerecis Limited | 2025 | — |
| +1 | K153364 | Kerecis SecureMesh | Kerecis Limited | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1985 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1996 | 4 | 0 |
| 1997 | 4 | 0 |
| 1998 | 6 | 0 |
| 1999 | 2 | 0 |
| 2000 | 8 | 0 |
| 2001 | 2 | 0 |
| 2002 | 5 | 0 |
| 2003 | 2 | 0 |
| 2004 | 3 | 0 |
| 2005 | 2 | 0 |
| 2006 | 3 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 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? (7)
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 |
|---|---|---|---|
| * | K092096 | Endoform Dermal TemplateSummary page 1…Classification Name: Collagen Wound Dressing 510k Number: K132343 3 PREDICATE DEVICES * Mesynthes Endloform N Dermal Template (K(092096) * ACeII MatriSte m T ' (1(092926) * Integra' Wound Matrix (Integra Life Sciences) (K(021792) " LifeCell Cor… | 2010 |
| * | K092926 | Acell Matristem Wound SheetSummary page 1…nd Dressing 510k Number: K132343 3 PREDICATE DEVICES * Mesynthes Endloform N Dermal Template (K(092096) * ACeII MatriSte m T ' (1(092926) * Integra' Wound Matrix (Integra Life Sciences) (K(021792) " LifeCell Corporation's LTM Wound Dressing (1(082103)… | 2009 |
| * | K021792 | Bilayer Matrix Wound DressingSummary page 1…CATE DEVICES * Mesynthes Endloform N Dermal Template (K(092096) * ACeII MatriSte m T ' (1(092926) * Integra' Wound Matrix (Integra Life Sciences) (K(021792) " LifeCell Corporation's LTM Wound Dressing (1(082103) " TOl Biosciences Inc. PriMatrix (K083440) * HemCon… | 2002 |
| * | K082103 | LTM Wound DressingSummary page 1…(092096) * ACeII MatriSte m T ' (1(092926) * Integra' Wound Matrix (Integra Life Sciences) (K(021792) " LifeCell Corporation's LTM Wound Dressing (1(082103) " TOl Biosciences Inc. PriMatrix (K083440) * HemCon Chitoflex Surgical Dressing (K(071519) * Cook Biotech,… | 2008 |
| * | K083440 | Primatrix Dermal Repair ScaffoldSummary page 1…* Integra' Wound Matrix (Integra Life Sciences) (K(021792) " LifeCell Corporation's LTM Wound Dressing (1(082103) " TOl Biosciences Inc. PriMatrix (K083440) * HemCon Chitoflex Surgical Dressing (K(071519) * Cook Biotech, Oasis (K(061711) Traditional 510k, K(132343… | 2008 |
| * | K071519 | Hemcon Chitoflex-Surgical DressingSummary page 1…K(021792) " LifeCell Corporation's LTM Wound Dressing (1(082103) " TOl Biosciences Inc. PriMatrix (K083440) * HemCon Chitoflex Surgical Dressing (K(071519) * Cook Biotech, Oasis (K(061711) Traditional 510k, K(132343 P… | 2007 |
| * | K061711 | Oasis Wound MatrixSummary page 1…s LTM Wound Dressing (1(082103) " TOl Biosciences Inc. PriMatrix (K083440) * HemCon Chitoflex Surgical Dressing (K(071519) * Cook Biotech, Oasis (K(061711) Traditional 510k, K(132343 Page 1… | 2006 |
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 21 years and passes through 5 companies; a new generation was cleared every 2.3 years on median.
- 5 of the 63 ancestors have a recall of any class.
- Of its descendants, K190528 (Kerecis Limited, 2019) has gone furthest, with 3 descendants of its own.
- 5 other devices also cite its predicate K092096.
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. 2013, 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?
MauiGen Wound Dressing is indicated for the management of wounds including:
- Partial- and MIl-thickness wounds
- Pressure ulcers
- venous ulcers
- Chronic vascular ulcers
- Diabetic ulcers
- Trauma wounds (abrasions, lacerations, second-degree bums, skin tears)
- Surgical wounds (donor sites/grafts, post-Mobs surgery, post-laser surgery, podiatric, wound dehiscence), and
- Draining wounds.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132343 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132343: Marigen Wound Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132343
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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