510(k) · Cleared
Recalled · Class II · 2026Cytal Wound Matrix
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 Dec 8, 2015 as substantially equivalent to K112409 (Acell, Inc., 2011) after a 78-day review. Its family tree reaches back 8 generations to 1992. 6 later devices descend from it. It has been recalled 5 times.
- Decided
- Dec 8, 2015
- Review
- 78 days
- Class
- Class U
- Product code
- KGN
- Recalls
- 5
- Predicates
- 1
Its longest line of descent runs back 8 generations to K921895 (1992). 26 ancestors in all, the oldest K830889 (1983). 6 later devices descend from it, 5 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 backK992159 Surgisis SlingCook Biotech, Inc. · 1999
- 4 generations backK001738 Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc. · 2000
- 3 generations backK021637 Acell Ubm Lyophilized Wound DressingAcell, Inc. · 2002
- 2 generations backK092926 Acell Matristem Wound SheetAcell, Inc. · 2009
- 1 generation backK112409 Matristem Wound MatrixAcell, Inc. · 2011
- This deviceK152721 Cytal Wound MatrixAcell, Inc. · 2015
- Descendant · cites it directly · 1 of its ownK192725 Cytal Wound Matrix 3-LayerAcell, Inc. · 2019
- Descendant · cites it directly · 1 of its ownK181330 NeoMatriX Wound MatrixNextgen Biologics, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK241724 Cytal® Wound Matrix; Cytal® Burn MatrixAcell, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK213607 Geistlich Wound Matrix PLUSGeistlich Pharma AG · 2022
- Descendant · 2 generations on · 0 of its ownK210024 NeoMatriX Wound MatrixNextgen Biologics, Inc. · 2021
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K192725Cytal Wound Matrix 3-LayerAcell, Inc. · 2019 · cites it directly1descendant
- K181330NeoMatriX Wound MatrixNextgen Biologics, Inc. · 2018 · cites it directly1descendant
- K241724Cytal® Wound Matrix; Cytal® Burn MatrixAcell, Inc. · 2024 · cites it directly0descendants
- K213607Geistlich Wound Matrix PLUSGeistlich Pharma AG · 2022 · cites it directly0descendants
- K210024NeoMatriX Wound MatrixNextgen Biologics, Inc. · 2021 · 2 generations on0descendants
View 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 | K992159 | Surgisis Sling | Cook Biotech, Inc. | 1999 | — |
| −4 | K001738 | Depuy Restore Orthobiologic Soft Tissue Implant | DePuy Orthopaedics, Inc. | 2000 | — |
| −3 | K021637 | Acell Ubm Lyophilized Wound Dressing | Acell, Inc. | 2002 | — |
| −2 | K092926 | Acell Matristem Wound Sheet | Acell, Inc. | 2009 | — |
| −1 | K112409 | Matristem Wound Matrix | Acell, Inc. | 2011 | — |
| 0 (this device) | K152721 | Cytal Wound Matrix | Acell, Inc. | 2015 | — |
| +1 | K192725 | Cytal Wound Matrix 3-Layer | Acell, Inc. | 2019 | — |
| +1 | K181330 | NeoMatriX Wound Matrix | Nextgen Biologics, Inc. | 2018 | — |
| +1 | K241724 | Cytal® Wound Matrix; Cytal® Burn Matrix | Acell, Inc. | 2024 | — |
| +1 | K213607 | Geistlich Wound Matrix PLUS | Geistlich Pharma AG | 2022 | — |
| +2 | K210024 | NeoMatriX Wound Matrix | Nextgen Biologics, Inc. | 2021 | — |
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 |
|---|---|---|
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K112409 | Matristem Wound MatrixSummary page 4…KGN Reviewing Panel: General & Plastic Surgery PREDICATE DEVICE Predicate Device: MatriStem ® Wound Matrix (K112409) DEVICE DESCRIPTION Cytal™ Wound Matrix is composed of porcine-derived extracellular matrix scaffolds, specifically known as uri… | 2011 |
What descends from it? (6)
5 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 |
|---|---|---|---|---|
| Mar 19, 2026 | Class II | Z-1816-2026 | Under Investigation by firm | Increased rate of out-of-specification endotoxin results. |
| Mar 19, 2026 | Class II | Z-1819-2026 | Under Investigation by firm | Increased rate of out-of-specification endotoxin results. |
| Mar 19, 2026 | Class II | Z-1817-2026 | Under Investigation by firm | Increased rate of out-of-specification endotoxin results. |
| Mar 19, 2026 | Class II | Z-1820-2026 | Under Investigation by firm | Increased rate of out-of-specification endotoxin results. |
| Mar 19, 2026 | Class II | Z-1818-2026 | Under Investigation by firm | Increased rate of out-of-specification endotoxin results. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 23 years and passes through 4 companies; a new generation was cleared every 2.0 years on median.
- 1 of the 26 ancestors has a recall of any class.
- Of its descendants, K192725 (Acell, Inc., 2019) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K112409.
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. 2015, 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?
Cytal® Wound Matrix is intended for the management of wounds including: partial and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunnel/undermined wounds, surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns, 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/K152721 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152721: Cytal Wound Matrix.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152721
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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