510(k) · Cleared
Recalled · Class II · 2018Endoform Dermal Template
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mesynthes, Ltd. · KGN Wound Dressing With Animal-Derived Material (S)
Cleared on Jan 21, 2010 as substantially equivalent to K061711 (Cook Biotech, Inc., 2006) and 5 other predicates after a 191-day review. Its family tree reaches back 6 generations to 1992. 19 later devices descend from it. It has been recalled 3 times.
- Decided
- Jan 21, 2010
- Review
- 191 days
- Class
- Class U
- Product code
- KGN
- Recalls
- 3
- Predicates
- 7
Its longest line of descent runs back 6 generations to K921895 (1992). 36 ancestors in all, the oldest K830889 (1983). 19 later devices descend from it, 6 citing it directly.
- Root · 6 generations backK921895 Tissue Patch, Tissue GraftBio-Vascular, Inc. · 1992
- 5 generations backK961810 Supple Peri-Guard PericardiumBio-Vascular, Inc. · 1996
- 4 generations backK980431 SurgisisCook Biotech, Inc. · 1998
- 3 generations backK992159 Surgisis SlingCook Biotech, Inc. · 1999
- 2 generations backK001738 Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc. · 2000
- 1 generation backK021637 Acell Ubm Lyophilized Wound DressingAcell, Inc. · 2002
- This deviceK092096 Endoform Dermal TemplateMesynthes, Ltd. · 2010
- Descendant · cites it directly · 5 of its ownK132343 Marigen Wound DressingKerecis Limited · 2013
- Descendant · cites it directly · 4 of its ownK200502 Myriad ParticlesAroa Biosurgery, Ltd. · 2021
- Descendant · 2 generations on · 3 of its ownK231325 Corplex P / Theracor P / Allacor PStimlabs, LLC · 2024
- Descendant · 2 generations on · 3 of its ownK190528 MariGen Wound ExtraKerecis Limited · 2019
- Descendant · cites it directly · 3 of its ownK171231 Endoform Topical MatrixAroa Biosurgery · 2017
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K132343Marigen Wound DressingKerecis Limited · 2013 · cites it directly5descendants
- K200502Myriad ParticlesAroa Biosurgery, Ltd. · 2021 · cites it directly4descendants
- K231325Corplex P / Theracor P / Allacor PStimlabs, LLC · 2024 · 2 generations on3descendants
- K190528MariGen Wound ExtraKerecis Limited · 2019 · 2 generations on3descendants
- K171231Endoform Topical MatrixAroa Biosurgery · 2017 · cites it directly3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K921895 | Tissue Patch, Tissue Graft | Bio-Vascular, Inc. | 1992 | — |
| −5 | K961810 | Supple Peri-Guard Pericardium | Bio-Vascular, Inc. | 1996 | — |
| −4 | K980431 | Surgisis | Cook Biotech, Inc. | 1998 | — |
| −3 | K992159 | Surgisis Sling | Cook Biotech, Inc. | 1999 | — |
| −2 | K001738 | Depuy Restore Orthobiologic Soft Tissue Implant | DePuy Orthopaedics, Inc. | 2000 | — |
| −1 | K021637 | Acell Ubm Lyophilized Wound Dressing | Acell, Inc. | 2002 | — |
| 0 (this device) | K092096 | Endoform Dermal Template | Mesynthes, Ltd. | 2010 | — |
| +1 | K132343 | Marigen Wound Dressing | Kerecis Limited | 2013 | — |
| +1 | K200502 | Myriad Particles | Aroa Biosurgery, Ltd. | 2021 | — |
| +2 | K231325 | Corplex P / Theracor P / Allacor P | Stimlabs, LLC | 2024 | — |
| +2 | K190528 | MariGen Wound Extra | Kerecis Limited | 2019 | — |
| +1 | K171231 | Endoform Topical Matrix | Aroa Biosurgery | 2017 | — |
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 | 1 | 0 |
| 1998 | 5 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 3 | 0 |
| 2025 | 3 | 0 |
| 2026 | 4 | 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K061711 | Oasis Wound Matrix | 2006 |
| Kept off the family tree | K073170 | FDA’s K073170 is R-Port II Laparoscopic Access Device Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2007 |
| * | K993948 | Sis Wound Dressing IISummary page 1…Endoform'~ Classification Name: Collagen Wound Dressing 3. PREDICATE DEVICES • OaSISO Wound Matrix (Cook Biotech) (1(06171 1, K(973 170, K993948) * UBM Lyophilized Wound Dressing (MatriSternYM) (ACeII) (1(021637) • Unite Biomnatrix"m (Pegasus Biologics) (K071425)… | 2000 |
| * | K021637 | Acell Ubm Lyophilized Wound DressingSummary page 1…Dressing 3. PREDICATE DEVICES • OaSISO Wound Matrix (Cook Biotech) (1(06171 1, K(973 170, K993948) * UBM Lyophilized Wound Dressing (MatriSternYM) (ACeII) (1(021637) • Unite Biomnatrix"m (Pegasus Biologics) (K071425) * Promogran® Matrix Wound Dressing (Johnson and Johnson) (1(014129… | 2002 |
| * | K071425 | Unite BiomatrixSummary page 1…ix (Cook Biotech) (1(06171 1, K(973 170, K993948) * UBM Lyophilized Wound Dressing (MatriSternYM) (ACeII) (1(021637) • Unite Biomnatrix"m (Pegasus Biologics) (K071425) * Promogran® Matrix Wound Dressing (Johnson and Johnson) (1(014129) * Integrae' Wound Matrix (Integra Life Sciences) (1(… | 2007 |
| * | K014129 | Promogran Matrix Wound DressingSummary page 1…ound Dressing (MatriSternYM) (ACeII) (1(021637) • Unite Biomnatrix"m (Pegasus Biologics) (K071425) * Promogran® Matrix Wound Dressing (Johnson and Johnson) (1(014129) * Integrae' Wound Matrix (Integra Life Sciences) (1(021792) 4. DEVICE DESCRIPTION Endoformn" Dermal Template is a woun… | 2002 |
| * | K021792 | Bilayer Matrix Wound DressingSummary page 1…iomnatrix"m (Pegasus Biologics) (K071425) * Promogran® Matrix Wound Dressing (Johnson and Johnson) (1(014129) * Integrae' Wound Matrix (Integra Life Sciences) (1(021792) 4. DEVICE DESCRIPTION Endoformn" Dermal Template is a wound dressing primarily composed of ovine collagen and is suppl… | 2002 |
What descends from it? (19)
See all 196 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 27, 2018 | Class II | Z-0378-2019 | Employee error | Potential for pouch seal failure |
| Nov 27, 2018 | Class II | Z-0379-2019 | Employee error | Potential for pouch seal failure |
| Nov 27, 2018 | Class II | Z-0377-2019 | Employee error | Potential for pouch seal failure |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 18 years and passes through 5 companies; a new generation was cleared every 2.0 years on median.
- 3 of the 36 ancestors have a recall of any class.
- Of its descendants, K132343 (Kerecis Limited, 2013) has gone furthest, with 5 descendants of its own.
- 15 other devices also cite its predicate K061711.
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. 2010, 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?
The Endoform Dermal Template is supplied sterile and is intended for single use in the treatment of the following wounds:
* partial and full-thickness wounds
* pressure ulcers
* venous ulcers
* diabetic ulcers
* chronic vascular ulcers
* tunneled/undermined wounds
* surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence)
* trauma wounds (abrasions, lacerations, second-degree burns, and skin tears)
* draining wounds
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092096 · printed Nov 4, 2026
Cite this page
510(k) Report. “K092096: Endoform Dermal Template.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092096
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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