510(k) · Cleared
ClearedMicroMatrix
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 6, 2017 as substantially equivalent to K152033 (Cook Biotech Incorporated, 2015) after a 59-day review. Its family tree reaches back 2 generations to 2006. 3 later devices descend from it.
- Decided
- Oct 6, 2017
- Review
- 59 days
- Class
- Class U
- Product code
- KGN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K061711 (2006). 3 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK061711 Oasis Wound MatrixCook Biotech, Inc. · 2006
- 1 generation backK152033 Cook ECM PowderCook Biotech Incorporated · 2015
- This deviceK172399 MicroMatrixAcell, Inc. · 2017
- Descendant · cites it directly · 1 of its ownK230980 MicroMatrix® FlexAcell, Inc. · 2023
- Descendant · 2 generations on · 0 of its ownK253521 Ecmt-100 WMDEcm Therapeutics, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK241706 MicroMatrix® UBM ParticulateAcell, Inc. · 2024
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 |
|---|---|---|---|---|---|
| −2 | K061711 | Oasis Wound Matrix | Cook Biotech, Inc. | 2006 | — |
| −1 | K152033 | Cook ECM Powder | Cook Biotech Incorporated | 2015 | — |
| 0 (this device) | K172399 | MicroMatrix | Acell, Inc. | 2017 | — |
| +1 | K230980 | MicroMatrix® Flex | Acell, Inc. | 2023 | — |
| +2 | K253521 | Ecmt-100 WMD | Ecm Therapeutics, Inc. | 2026 | — |
| +1 | K241706 | MicroMatrix® UBM Particulate | Acell, Inc. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K152033 | Cook ECM PowderSummary page 4…evice Class: Unclassified Product Code: KGN Reviewing Panel: General & Plastic Surgery PREDICATE DEVICE Primary Predicate Device: Cook Biotech Inc. Cook® ECM Powder (K152033) Reference Devices: ACell Inc. MicroMatrix® (K153754) ACell Inc. Cytal™ Wound Matrix (K152721) DEVICE DESCRIPTION MicroMatrix®… | 2015 |
| † | K153754 | MicroMatrix | 2016 |
| † | K152721 | Cytal Wound Matrix | 2015 |
What descends from it? (3)
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 11 years and passes through 3 companies; a new generation was cleared every 9.1 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K230980 (Acell, Inc., 2023) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K152033.
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. 2017, 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?
MicroMatrix® 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K172399 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172399: MicroMatrix.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172399
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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