510(k) · Cleared

Cleared

Ecmt-100 WMD

K253521510(k) TraditionalCleared Jun 18, 2026217-day reviewClass U

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Ecm Therapeutics, Inc. · KGN Wound Dressing With Animal-Derived Material (S)

Cleared on Jun 18, 2026 as substantially equivalent to K230980 (Acell, Inc., 2023) after a 217-day review. Its family tree reaches back 4 generations to 2006.

Decided: Jun 18, 2026
Review: 217 days
Class: Class U
Product code: KGN
Recalls: None
Predicates: 1

Its longest line of descent runs back 4 generations to K061711 (2006). No later device cites it as a predicate yet.

By dateBy generation

Root · 4 generations backK061711 Oasis Wound MatrixCook Biotech, Inc. · 2006
3 generations backK152033 Cook ECM PowderCook Biotech Incorporated · 2015
2 generations backK172399 MicroMatrixAcell, Inc. · 2017
1 generation backK230980 MicroMatrix® FlexAcell, Inc. · 2023
This deviceK253521 Ecmt-100 WMDEcm Therapeutics, Inc. · 2026

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K061711	Oasis Wound Matrix	Cook Biotech, Inc.	2006	—
−3	K152033	Cook ECM Powder	Cook Biotech Incorporated	2015	—
−2	K172399	MicroMatrix	Acell, Inc.	2017	—
−1	K230980	MicroMatrix® Flex	Acell, Inc.	2023	—
0 (this device)	K253521	Ecmt-100 WMD	Ecm Therapeutics, Inc.	2026	—

FIG. 1 — Lineage of K253521, 2006–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K230980	MicroMatrix® Flex Summary page 6 …. 3. PREDICATE DEVICE INFORMATION Device Name: MicroMatrix® Flex 510(k) Number: K230980 Manufacturer: ACell, Inc. (subsidiary of Integra LifeSciences Corp.) The predicate device has not been su…	Acell, Inc.	2023	—

What descends from it?

No later submission names this one as a predicate yet.

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 20 years and passes through 4 companies; a new generation was cleared every 6.0 years on median.
None of the 4 ancestors has a recall.

How does its category compare?

All KGN devices

KGN Wound Dressing With Animal-Derived Material (S): FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.

FDA decisions per year · KGN

15so far in 2026, the most since 2007

2007high 15 (2026) · low 3 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KGN

162in 2025

2007high 279 (2020) · low 32 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · KGN

3in 2018

2007high 3 (2018) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · KGN

15in 2025

2007high 21 (2023) · low 0 (2007)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?

ECMT-100 WMD 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), draining wounds. The device is intended for single-use.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K253521 · printed Nov 6, 2026

Cite this page

510(k) Report. “K253521: Ecmt-100 WMD.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K253521

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Record history

FDA decision record loaded Oct 30, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026