510(k) · Cleared
ClearedMariGen Wound Extra
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 Jul 10, 2019 as substantially equivalent to K132343 (Kerecis Limited, 2013) after a 128-day review. Its family tree reaches back 8 generations to 1992. 3 later devices descend from it.
- Decided
- Jul 10, 2019
- Review
- 128 days
- Class
- Class U
- Product code
- KGN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K921895 (1992). 64 ancestors in all, the oldest K830889 (1983). 3 later devices descend from it, 3 citing it directly.
- Root · 8 generations backK921895 Tissue Patch, Tissue GraftBio-Vascular, Inc. · 1992
- 7 generations backK961810 Supple Peri-Guard PericardiumBio-Vascular, Inc. · 1996
- 6 generations backK980431 SurgisisCook Biotech, Inc. · 1998
- 5 generations backK043366 Permacol Surgical ImplantTissue Science Laboratories, Plc · 2004
- 4 generations backK050355 Permacol Surgical Implant T-Piece, Permacol Surgical Implant…Tissue Science Laboratories, Plc · 2005
- 3 generations backK070560 LRTM Surgical MeshLifecell Corp. · 2007 · Recalled
- 2 generations backK082103 LTM Wound DressingLifecell Corp. · 2008
- 1 generation backK132343 Marigen Wound DressingKerecis Limited · 2013
- This deviceK190528 MariGen Wound ExtraKerecis Limited · 2019
- Descendant · cites it directly · 1 of its ownK241080 Kerecis Parvus (50207)Kerecis Limited · 2024
- Descendant · cites it directly · 1 of its ownK213231 Kerecis SiliconeKerecis Limited · 2022
- Descendant · cites it directly · 0 of its ownK251845 Marigen Wound Extra; Kerecis Silicone; Kerecis ParvusKerecis Limited · 2025
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K921895 | Tissue Patch, Tissue Graft | Bio-Vascular, Inc. | 1992 | — |
| −7 | K961810 | Supple Peri-Guard Pericardium | Bio-Vascular, Inc. | 1996 | — |
| −6 | K980431 | Surgisis | Cook Biotech, Inc. | 1998 | — |
| −5 | K043366 | Permacol Surgical Implant | Tissue Science Laboratories, Plc | 2004 | — |
| −4 | K050355 | Permacol Surgical Implant T-Piece, Permacol Surgical Implant Rectocele-Piece… | Tissue Science Laboratories, Plc | 2005 | — |
| −3 | K070560 | LRTM Surgical Mesh | Lifecell Corp. | 2007 | 2 |
| −2 | K082103 | LTM Wound Dressing | Lifecell Corp. | 2008 | — |
| −1 | K132343 | Marigen Wound Dressing | Kerecis Limited | 2013 | — |
| 0 (this device) | K190528 | MariGen Wound Extra | Kerecis Limited | 2019 | — |
| +1 | K241080 | Kerecis Parvus (50207) | Kerecis Limited | 2024 | — |
| +1 | K213231 | Kerecis Silicone | Kerecis Limited | 2022 | — |
| +1 | K251845 | Marigen Wound Extra; Kerecis Silicone; Kerecis Parvus | Kerecis Limited | 2025 | — |
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 |
|---|---|---|
| 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? (1)
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 |
|---|---|---|---|
| * | K132343 | Marigen Wound DressingSummary page 4…ual Name: Collagen, Wound, Dressing Class: Unclassified Product code: KGN PREDICATE DEVICE MariGen Wound (K132343), predicate device SecureMesh (K153364), reference device DEVICE DESCRIPTION The subject device is processed fish dermal mat… | 2013 |
| † | K153364 | Kerecis SecureMesh | 2016 |
What descends from it? (3)
3 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 27 years and passes through 5 companies; a new generation was cleared every 3.6 years on median.
- 5 of the 64 ancestors have a recall of any class.
- Of its descendants, K241080 (Kerecis Limited, 2024) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K132343.
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. 2019, 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?
MariGen Wound Extra is indicated for the management of wounds, including:
- Partial and full-thickness wounds
- Pressure ulcers
- Venous ulcers
- Chronic vascular ulcers
- Diabetic ulcers
- Trauma wounds (second degree burn, abrasions, lacerations, skin tears),
- Surgical wounds (donor sites/grafts, post-Mohs surgery, post laser surgery, podiatric, wound dehiscence),
- Draining wounds.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190528 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190528: MariGen Wound Extra.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190528
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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