510(k) · Cleared

Cleared

Excellagen

K110318510(k) TraditionalCleared Oct 3, 2011243-day reviewClass U

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

Tissue Repair Company · KGN Wound Dressing With Animal-Derived Material (S)

Cleared on Oct 3, 2011 as substantially equivalent to K072113 (Integra Lifesciences Corp., 2007) and 5 other predicates after a 243-day review. Its family tree reaches back 5 generations to 1988.

Decided: Oct 3, 2011
Review: 243 days
Class: Class U
Product code: KGN
Recalls: None
Predicates: 6

Its longest line of descent runs back 5 generations to K881854 (1988). 15 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 5 generations backK881854 Sorbsan Topical Wound DressingE.G. Dick & Assoc. · 1988
4 generations backK982597 Fibrcol Plus Collagen Wound Dressing with AlginateJohnson & Johnson Medical, Inc. · 1998
3 generations backK993948 Sis Wound Dressing IICook Biotech, Inc. · 2000
2 generations backK022127 Avagen Wound DressingIntegra Lifesciences Corp. · 2002
1 generation backK072113 Integra Flowable Wound Matrix, Model FWD301Integra Lifesciences Corp. · 2007 · Recalled
This deviceK110318 ExcellagenTissue Repair Company · 2011

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−5	K881854	Sorbsan Topical Wound Dressing	E.G. Dick & Assoc.	1988	—
−4	K982597	Fibrcol Plus Collagen Wound Dressing with Alginate	Johnson & Johnson Medical, Inc.	1998	—
−3	K993948	Sis Wound Dressing II	Cook Biotech, Inc.	2000	—
−2	K022127	Avagen Wound Dressing	Integra Lifesciences Corp.	2002	—
−1	K072113	Integra Flowable Wound Matrix, Model FWD301	Integra Lifesciences Corp.	2007	1
0 (this device)	K110318	Excellagen	Tissue Repair Company	2011	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1991	3	0
1993	1	0
1996	1	0
1998	1	0
1999	1	0
2001	1	0
2002	1	0
2004	1	0

FIG. 1 — Lineage of K110318, 1988–2011Source: 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? (6)

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
*	K072113	Integra Flowable Wound Matrix, Model FWD301 Summary page 1 …Collagen Wound Dressing Classification Name: Dressing, Wound, Collagen Product Code: KON Predicate Devices Integra Flowable Wound Matrix, K0721 13 Stimulen Collagen, K030774 Medifil gel, K910944 HyCure Hydrolyzed Collagen, K955506 Collatek Powder, K012990 HeliDerm Collagen Wo…	Integra Lifesciences Corp.	2007	1
*	K030774	Stimulen Collagen Summary page 1 …essing Classification Name: Dressing, Wound, Collagen Product Code: KON Predicate Devices Integra Flowable Wound Matrix, K0721 13 Stimulen Collagen, K030774 Medifil gel, K910944 HyCure Hydrolyzed Collagen, K955506 Collatek Powder, K012990 HeliDerm Collagen Wound Dressing, K990086 Dev…	Southwest Technologies, Inc.	2004	1
*	K910944	Medifil Summary page 1 …Name: Dressing, Wound, Collagen Product Code: KON Predicate Devices Integra Flowable Wound Matrix, K0721 13 Stimulen Collagen, K030774 Medifil gel, K910944 HyCure Hydrolyzed Collagen, K955506 Collatek Powder, K012990 HeliDerm Collagen Wound Dressing, K990086 Device Description Excel…	Biocore	1991	—
*	K955506	Hycure Summary page 1 …en Product Code: KON Predicate Devices Integra Flowable Wound Matrix, K0721 13 Stimulen Collagen, K030774 Medifil gel, K910944 HyCure Hydrolyzed Collagen, K955506 Collatek Powder, K012990 HeliDerm Collagen Wound Dressing, K990086 Device Description Excellagen is a wound care device compose…	The Hymed Group Corp.	1996	—
*	K012990	Collatek Powder Summary page 1 …KON Predicate Devices Integra Flowable Wound Matrix, K0721 13 Stimulen Collagen, K030774 Medifil gel, K910944 HyCure Hydrolyzed Collagen, K955506 Collatek Powder, K012990 HeliDerm Collagen Wound Dressing, K990086 Device Description Excellagen is a wound care device composed of formulated, 2.6% (26…	Biocore Medical Technologies, Inc.	2001	—
*	K990086	Heliderm Collagen Wound Dressings 0.5 Gram and 1.0 Gram Summary page 1 …ble Wound Matrix, K0721 13 Stimulen Collagen, K030774 Medifil gel, K910944 HyCure Hydrolyzed Collagen, K955506 Collatek Powder, K012990 HeliDerm Collagen Wound Dressing, K990086 Device Description Excellagen is a wound care device composed of formulated, 2.6% (26 mg/mL) fibrillar bovine dermal Collagen (…	Integra Lifesciences Corp.	1999	—

Also cleared against K072113: 4 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?

The line of descent spans 23 years and passes through 5 companies; a new generation was cleared every 4.0 years on median.
2 of the 15 ancestors have a recall of any class.
4 other devices also cite its predicate K072113.

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. 2011, 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?

Excellagen is indicated 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, second-degree burns, and skin tears) and draining wounds. This device is packaged 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/K110318 · printed Nov 4, 2026

Cite this page

510(k) Report. “K110318: Excellagen.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K110318

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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