510(k) · Cleared

Cleared

Flowable Wound Matrix

K160136510(k) TraditionalCleared Sep 28, 2016252-day reviewClass U

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

Cook Biotech Incorporated · KGN Wound Dressing With Animal-Derived Material (S)

Cleared on Sep 28, 2016 as substantially equivalent to K061711 (Cook Biotech, Inc., 2006) after a 252-day review. Its family tree reaches back 1 generation to 2006.

Decided: Sep 28, 2016
Review: 252 days
Class: Class U
Product code: KGN
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K061711 (2006). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK061711 Oasis Wound MatrixCook Biotech, Inc. · 2006
This deviceK160136 Flowable Wound MatrixCook Biotech Incorporated · 2016

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K061711	Oasis Wound Matrix	Cook Biotech, Inc.	2006	—
0 (this device)	K160136	Flowable Wound Matrix	Cook Biotech Incorporated	2016	—

FIG. 1 — Lineage of K160136, 2006–2016Source: 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
*	K061711	Oasis Wound Matrix Summary page 4 …KGN Device Class: The product code KGN is considered by FDA to be unclassified. Predicate Device: Oasis Wound Matrix (K061711) Reference Devices: Integra Flowable Wound Matrix (K072113) Cook ECM Powder (K152033) MicroMatrix (K153754) Intended Use: The F…	Cook Biotech, Inc.	2006	—
†	K072113	Integra Flowable Wound Matrix, Model FWD301	Integra Lifesciences Corp.	2007	1
†	K152033	Cook ECM Powder	Cook Biotech Incorporated	2015	—
†	K153754	MicroMatrix	Acell, Inc.	2016	—

Also cleared against K061711: 15 other devices →

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?

Its one ancestor has no recall.
15 other devices also cite its predicate K061711.

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. 2016, 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?

The Flowable Wound Matrix 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, 2nd degree burns, skin tears),

- draining wounds.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K160136 · printed Nov 5, 2026

Cite this page

510(k) Report. “K160136: Flowable Wound Matrix.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K160136

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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