510(k) · Cleared
ClearedMicroMatrix® Flex
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 Sep 22, 2023 as substantially equivalent to K172399 (Acell, Inc., 2017) after a 170-day review. Its family tree reaches back 3 generations to 2006. 1 later device descends from it.
- Decided
- Sep 22, 2023
- Review
- 170 days
- Class
- Class U
- Product code
- KGN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K061711 (2006). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK061711 Oasis Wound MatrixCook Biotech, Inc. · 2006
- 2 generations backK152033 Cook ECM PowderCook Biotech Incorporated · 2015
- 1 generation backK172399 MicroMatrixAcell, Inc. · 2017
- This deviceK230980 MicroMatrix® FlexAcell, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK253521 Ecmt-100 WMDEcm Therapeutics, Inc. · 2026
Most influential descendants
Showing 1 of 1 · See all- K253521Ecmt-100 WMDEcm Therapeutics, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K061711 | Oasis Wound Matrix | Cook Biotech, Inc. | 2006 | — |
| −2 | K152033 | Cook ECM Powder | Cook Biotech Incorporated | 2015 | — |
| −1 | K172399 | MicroMatrix | Acell, Inc. | 2017 | — |
| 0 (this device) | K230980 | MicroMatrix® Flex | Acell, Inc. | 2023 | — |
| +1 | K253521 | Ecmt-100 WMD | Ecm Therapeutics, Inc. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K172399 | MicroMatrixSummary page 4…ation Name: Collagen Wound Dressing Regulation Number: N/A Regulatory Class: Unclassified FDA Product Code: KGN Predicate Device: MicroMatrix® UBM Particulate (K172399) Reference Devices: • Cook Biotech Inc. – Flowable Wound Matrix (K160136) • Integra Lifesciences Corp. – Integra Flowab… | 2017 |
| † | K160136 | Flowable Wound Matrix | 2016 |
| † | K072113 | Integra Flowable Wound Matrix, Model FWD301 | 2007 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K253521 | Ecmt-100 WMD | 2026 | 0 |
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 3 companies; a new generation was cleared every 6.0 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K253521 (Ecm Therapeutics, Inc., 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K172399.
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. 2023, 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® Flex 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-Mohs surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, partial thickness burns, 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/K230980 · printed Nov 4, 2026
Cite this page
510(k) Report. “K230980: MicroMatrix® Flex.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K230980
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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