510(k) · Cleared
ClearedAcell Matristem Wound Sheet
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Acell, Inc. · KGN Wound Dressing With Animal-Derived Material (S)
Cleared on Oct 28, 2009 as substantially equivalent to K021637 (Acell, Inc., 2002) after a 35-day review. Its family tree reaches back 6 generations to 1992. 14 later devices descend from it.
- Decided
- Oct 28, 2009
- Review
- 35 days
- Class
- Class U
- Product code
- KGN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K921895 (1992). 24 ancestors in all, the oldest K830889 (1983). 14 later devices descend from it, 2 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 deviceK092926 Acell Matristem Wound SheetAcell, Inc. · 2009
- Descendant · cites it directly · 7 of its ownK112409 Matristem Wound MatrixAcell, Inc. · 2011
- Descendant · 2 generations on · 6 of its ownK152721 Cytal Wound MatrixAcell, Inc. · 2015 · Recalled
- Descendant · cites it directly · 5 of its ownK132343 Marigen Wound DressingKerecis Limited · 2013
- Descendant · 2 generations on · 3 of its ownK190528 MariGen Wound ExtraKerecis Limited · 2019
- Descendant · 3 generations on · 1 of its ownK241080 Kerecis Parvus (50207)Kerecis Limited · 2024
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K112409Matristem Wound MatrixAcell, Inc. · 2011 · cites it directly7descendants
- K152721Cytal Wound MatrixAcell, Inc. · 2015 · 2 generations on6descendants
- K132343Marigen Wound DressingKerecis Limited · 2013 · cites it directly5descendants
- K190528MariGen Wound ExtraKerecis Limited · 2019 · 2 generations on3descendants
- K241080Kerecis Parvus (50207)Kerecis Limited · 2024 · 3 generations on1descendant
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) | K092926 | Acell Matristem Wound Sheet | Acell, Inc. | 2009 | — |
| +1 | K112409 | Matristem Wound Matrix | Acell, Inc. | 2011 | — |
| +2 | K152721 | Cytal Wound Matrix | Acell, Inc. | 2015 | 5 |
| +1 | K132343 | Marigen Wound Dressing | Kerecis Limited | 2013 | — |
| +2 | K190528 | MariGen Wound Extra | Kerecis Limited | 2019 | — |
| +3 | K241080 | Kerecis Parvus (50207) | Kerecis Limited | 2024 | — |
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 | 3 | 0 |
| 1997 | 1 | 0 |
| 1998 | 5 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2024 | 2 | 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 |
|---|---|---|---|
| * | K021637 | Acell Ubm Lyophilized Wound DressingSummary page 1…s, skin tears) and draining wounds. The device is intended for one-time use. Predicate Device: 510(k) # Device Manufacturer K021637 ACell® UBM Lyophilized Wound Dressing ACelI, Inc. Substantial Equivalence: ACell® MatriStem® Wound Sheets are ide… | 2002 |
What descends from it? (14)
See all 142 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 17 years and passes through 4 companies; a new generation was cleared every 2.0 years on median.
- 1 of the 24 ancestors has a recall of any class.
- Of its descendants, K112409 (Acell, Inc., 2011) has gone furthest, with 7 descendants of its own.
- 4 other devices also cite its predicate K021637.
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. 2009, 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?
ACell® MatriStem® Wound Sheet is intended for the management of wounds including: 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 bums and skin tears) and draining wounds. The device is intended for one-time use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092926 · printed Nov 4, 2026
Cite this page
510(k) Report. “K092926: Acell Matristem Wound Sheet.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092926
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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