510(k) Report

510(k) · Cleared

Cleared

Avagen Wound Dressing

K022127510(k) TraditionalCleared Sep 10, 200271-day reviewClass U

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

Integra Lifesciences Corp. · KGN Wound Dressing With Animal-Derived Material (S)

Cleared on Sep 10, 2002 as substantially equivalent to K993948 (Cook Biotech, Inc., 2000) and 1 other predicate after a 71-day review. Its family tree reaches back 3 generations to 1988. 28 later devices descend from it.

Decided
Sep 10, 2002
Review
71 days
Class
Class U
Product code
KGN
Recalls
None
Predicates
2

Its longest line of descent runs back 3 generations to K881854 (1988). 9 ancestors in all. 28 later devices descend from it, 10 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2002: 1 other ancestor1998: 1 other ancestor1991: 3 other ancestors1993: 1 other ancestor2014: 4 descendants cleared2009: 1 descendant cleared2025: 2 descendants cleared2020: 2 descendants cleared2012: 1 descendant cleared2007: 1 descendant cleared2022: 2 descendants cleared2021: 1 descendant cleared2011: 2 descendants cleared2008: 1 descendant cleared2017: 3 descendants cleared2016: 1 descendant cleared2018: 1 descendant cleared2024: 2 descendants cleared2026: 2 descendants cleared2023: 2 descendants clearedK881854 · Sorbsan Topical Wound Dressing · E.G. Dick & Assoc. · 1988K982597 · Fibrcol Plus Collagen Wound Dressing with Alginate · Johnson & Johnson Medical, Inc. · 1998K993948 · Sis Wound Dressing II · Cook Biotech, Inc. · 20001990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 3 other ancestors3 generations back: 2 other ancestors 1 generation forward: 10 descendants2 generations forward: 10 descendants3 generations forward: 6 descendants4 generations forward: 2 descendants K993948 · Sis Wound Dressing II · Cook Biotech, Inc. · 2000K982597 · Fibrcol Plus Collagen Wound Dressing with Alginate · Johnson & Johnson Medical, Inc. · 1998K881854 · Sorbsan Topical Wound Dressing · E.G. Dick & Assoc. · 19880
  1. Root · 3 generations backK881854 Sorbsan Topical Wound DressingE.G. Dick & Assoc. · 1988
  2. 2 generations backK982597 Fibrcol Plus Collagen Wound Dressing with AlginateJohnson & Johnson Medical, Inc. · 1998
  3. 1 generation backK993948 Sis Wound Dressing IICook Biotech, Inc. · 2000
  4. This deviceK022127 Avagen Wound DressingIntegra Lifesciences Corp. · 2002
  5. Descendant · cites it directly · 10 of its ownK132397 Gore Bio-a Wound MatrixW. L. Gore & Associates, Inc. · 2014
  6. Descendant · cites it directly · 5 of its ownK072113 Integra Flowable Wound Matrix, Model FWD301Integra Lifesciences Corp. · 2007 · Recalled
  7. Descendant · 2 generations on · 4 of its ownK170300 Restrata Wound MatrixAcera Surgical, Inc. · 2017 · Recalled
  8. Descendant · 2 generations on · 3 of its ownK161067 Mirragen Advanced Wound Matrix, 4x4”, Mirragen Advanced Wound…Engineered Tissue Solutions, LLC · 2016
  9. Descendant · 3 generations on · 2 of its ownK222189 SiOxD Wound MatrixSioxmed, LLC · 2022

Showing 5 of 28 descendants. See all descendants

Descendants cleared per year

2007: 12008: 12009: 12011: 22012: 12014: 42016: 12017: 32018: 12020: 22021: 12022: 22023: 22024: 22025: 22026: 2
2007high 4 (2014) · low 0 (2010)2026

Most influential descendants

Showing 5 of 28 · See all
  • K132397Gore Bio-a Wound MatrixW. L. Gore & Associates, Inc. · 2014 · cites it directly10descendants
  • K072113Integra Flowable Wound Matrix, Model FWD301Integra Lifesciences Corp. · 2007 · cites it directly5descendants
  • K170300Restrata Wound MatrixAcera Surgical, Inc. · 2017 · 2 generations on4descendants
  • K161067Mirragen Advanced Wound Matrix, 4x4”, Mirragen Advanced Wound Matrix, 2x2”, Mirragen…Engineered Tissue Solutions, LLC · 2016 · 2 generations on3descendants
  • K222189SiOxD Wound MatrixSioxmed, LLC · 2022 · 3 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K881854Sorbsan Topical Wound DressingE.G. Dick & Assoc.1988—
−2K982597Fibrcol Plus Collagen Wound Dressing with AlginateJohnson & Johnson Medical, Inc.1998—
−1K993948Sis Wound Dressing IICook Biotech, Inc.2000—
0 (this device)K022127Avagen Wound DressingIntegra Lifesciences Corp.2002—
+1K132397Gore Bio-a Wound MatrixW. L. Gore & Associates, Inc.2014—
+1K072113Integra Flowable Wound Matrix, Model FWD301Integra Lifesciences Corp.20071
+2K170300Restrata Wound MatrixAcera Surgical, Inc.20171
+2K161067Mirragen Advanced Wound Matrix, 4x4”, Mirragen Advanced Wound Matrix, 2x2”…Engineered Tissue Solutions, LLC2016—
+3K222189SiOxD Wound MatrixSioxmed, LLC2022—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199130
199310
199810
200210

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
200810
200910
201120
201210
201440
201610
201730
201810
202020
202110
202220
202320
202420
202520
202620
FIG. 1 — Lineage of K022127, 1988–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K231325 Corplex P / Theracor P / Allacor Pscore 17.9 · 8 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (2)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K993948Sis Wound Dressing II
Summary page 1
…function and intended use to the following products which have been cleared to market under Premarket Notifications 5 lO(k): OasisTMSIS Wound Dressing 11 (K993948) and FortadennTMWound Dressing (KO 14129). Intended Use: AVAGEN Wound Dressing is indicated for the management of w…
Cook Biotech, Inc.2000—
*K014129Promogran Matrix Wound DressingJohnson & Johnson Medical, Ltd.2002—

Also cleared against K993948: 9 other devices →

What descends from it? (28)

See all 28

10 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K132397Gore Bio-a Wound MatrixW. L. Gore & Associates, Inc.201410
K072113Integra Flowable Wound Matrix, Model FWD301Integra Lifesciences Corp.20075
K090894Collawound Wound DressingCollamatrix Co., Inc.20092
K130557Neuragen 3DIntegra LifeSciences Corporation20141
K241904DermiSphere Dermal TemplateFesariustherapeutics, Inc.20250
K213573PELNAC Wound MatrixGunze Limited20220
K210128INTEGRA Wound Matrix (Macro-Channels)Integra LifeSciences Corporation20210
K191992PELNAC Bilayer Wound MatrixGunze Limited20200
K140456Bio-Connekt Wound MatrixMLM Biologics, Inc.20140
K113104Integra Wound Matrix (Thin)Integra LifeSciences Corporation20120

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 14 years and passes through 4 companies; a new generation was cleared every 2.7 years on median.
  • None of the 9 ancestors has a recall.
  • Of its descendants, K132397 (W. L. Gore & Associates, Inc., 2014) has gone furthest, with 10 descendants of its own.
  • 9 other devices also cite its predicate K993948.

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.

FDA decisions per year · KGN

15so far in 2026, the most since 2007

2007: 32008: 62009: 82010: 42011: 72012: 82013: 62014: 52015: 72016: 42017: 72018: 62019: 32020: 52021: 62022: 122023: 92024: 132025: 102026 (partial year): 15
2007high 15 (2026) · low 3 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KGN

162in 2025

2007: 32 days median2008: 87 days median2009: 121 days median2010: 175 days median2011: 228 days median2012: 123 days median2013: 147 days median2014: 188 days median2015: 87 days median2016: 164 days median2017: 136 days median2018: 148 days median2019: 128 days median2020: 279 days median2021: 236 days median2022: 246 days median2023: 194 days median2024: 83 days median2025: 162 days median2026 (partial year): 174 days median
2007high 279 (2020) · low 32 (2007)2026

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

Recalls per year · KGN

3in 2018

2017: 12018: 3
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

2008: 12009: 22010: 32011: 62012: 42013: 62014: 122015: 92016: 62017: 82018: 152019: 112020: 172021: 142022: 132023: 212024: 152025: 15
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200733200
200868701
2009812102
2010417503
2011722806
2012812304
2013614706
20145188012
201578709
2016416406
2017713618
20186148315
20193128011
20205279017
20216236014
202212246013
20239194021
20241383015
202510162015
2026151740—

What is it indicated for?

AVAGEN Wound Dressing is indicated for the management of wollnds including: partial and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneledundermined wounds, surgical wounds (donor sitedgrafts, post-Moh’s surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree bums, skin tears) and draining wounds. The device is intended for one-time use.

Indications for use as stated in the FDA summary.

Also cleared against K993948

9 other devices cite the same predicate.

  • K092096Endoform Dermal TemplateMesynthes, Ltd. · 20103 recalls
  • K090894Collawound Wound DressingCollamatrix Co., Inc. · 2009
  • K040314HealicollEncoll Corp. · 2004
  • K023778DressskinTei Biosciences, Inc. · 2003
  • K022854Acell Ubm Hydrated Wound DressingAcell, Inc. · 2002
  • K021637Acell Ubm Lyophilized Wound DressingAcell, Inc. · 2002

More from Integra Lifesciences Corp.

240 FDA decisions under this applicant name. See the company

  • P900033/S117INTEGRA ® Dermal Regeneration Template, Integra® Meshed Dermal Regeneration Template, and Integra® Omnigraft…Integra Lifesciences Corp. · 2026
  • P840062/S099CollaCote™, CollaTape®, CollaPlug®, Absorbable Collagen Wound Dressings for Dental SurgeryIntegra Lifesciences Corp. · 2026
  • P840062/S098CollaCote™, CollaTape®, CollaPlug®, Absorbable Collagen Wound Dressings for Dental SurgeryIntegra Lifesciences Corp. · 2026
  • P840062/S097CollaCote® and CollaTape® Absorbable Collagen Wound Dressings for Dental SurgeryIntegra Lifesciences Corp. · 2026
  • P900033/S116INTEGRA ® Dermal Regeneration Template; Integra® Meshed Dermal Regeneration Template; Integra® Omnigraft…Integra Lifesciences Corp. · 2026

Recent decisions in KGN

The KGN category page

  • K260920Accelagen Advanced Surgical Collagen Matrix, 1cc (CG-01AA); Accelagen Advanced Surgical Collagen Matrix, 2cc…Berkeley Advanced Biomaterials · 2026
  • K260530epi-ConneKt™ Wound MatrixMLM Biologics, Inc. · 2026
  • K260652ColActive PlusCovalon Technologies, Ltd. · 2026
  • K260711Accelagen Plus Surgical Matrix, 1cc (CG-01AP);Accelagen Plus Surgical Matrix, 3cc (CG-03AP);Accelagen Plus…Berkeley Advanced Biomaterials · 2026
  • K260596Collagen Wound PowderVentris Medical · 2026

https://510kreport.com/device/K022127 · printed Nov 4, 2026

Cite this page

510(k) Report. “K022127: Avagen Wound Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K022127

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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