510(k) Report

510(k) · Cleared

Cleared

Collawound Dressing

K061474510(k) TraditionalCleared Jul 5, 200636-day reviewClass U

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

Collamatrix Co., Inc. · KGN Wound Dressing With Animal-Derived Material (S)

Cleared on Jul 5, 2006 as substantially equivalent to K021637 (Acell, Inc., 2002) and 5 other predicates after a 36-day review. Its family tree reaches back 6 generations to 1992. 3 later devices descend from it.

Decided
Jul 5, 2006
Review
36 days
Class
Class U
Product code
KGN
Recalls
None
Predicates
6

Its longest line of descent runs back 6 generations to K921895 (1992). 30 ancestors in all, the oldest K830889 (1983). 3 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2003: 1 other ancestor2002: 1 other ancestor2001: 2 other ancestors1991: 3 other ancestors2000: 1 other ancestor1999: 1 other ancestor1998: 5 other ancestors1994: 1 other ancestor1993: 1 other ancestor1997: 1 other ancestor1988: 1 other ancestor1996: 3 other ancestors1992: 1 other ancestor1985: 1 other ancestor1983: 1 other ancestor2009: 1 descendant cleared2017: 1 descendant cleared2024: 1 descendant clearedK921895 · Tissue Patch, Tissue Graft · Bio-Vascular, Inc. · 1992K961810 · Supple Peri-Guard Pericardium · Bio-Vascular, Inc. · 1996K980431 · Surgisis · Cook Biotech, Inc. · 1998K992159 · Surgisis Sling · Cook Biotech, Inc. · 1999K001738 · Depuy Restore Orthobiologic Soft Tissue Implant · DePuy Orthopaedics, Inc. · 2000K021637 · Acell Ubm Lyophilized Wound Dressing · Acell, Inc. · 200219801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 5 other ancestors2 generations back: 5 other ancestors3 generations back: 7 other ancestors4 generations back: 7 other ancestors 1 generation forward: 1 descendant2 generations forward: 1 descendant3 generations forward: 1 descendant K021637 · Acell Ubm Lyophilized Wound Dressing · Acell, Inc. · 2002K001738 · Depuy Restore Orthobiologic Soft Tissue Implant · DePuy Orthopaedics, Inc. · 2000K992159 · Surgisis Sling · Cook Biotech, Inc. · 1999K980431 · Surgisis · Cook Biotech, Inc. · 1998K961810 · Supple Peri-Guard Pericardium · Bio-Vascular, Inc. · 1996K921895 · Tissue Patch, Tissue Graft · Bio-Vascular, Inc. · 1992−50
  1. Root · 6 generations backK921895 Tissue Patch, Tissue GraftBio-Vascular, Inc. · 1992
  2. 5 generations backK961810 Supple Peri-Guard PericardiumBio-Vascular, Inc. · 1996
  3. 4 generations backK980431 SurgisisCook Biotech, Inc. · 1998
  4. 3 generations backK992159 Surgisis SlingCook Biotech, Inc. · 1999
  5. 2 generations backK001738 Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc. · 2000
  6. 1 generation backK021637 Acell Ubm Lyophilized Wound DressingAcell, Inc. · 2002
  7. This deviceK061474 Collawound DressingCollamatrix Co., Inc. · 2006
  8. Descendant · cites it directly · 2 of its ownK090894 Collawound Wound DressingCollamatrix Co., Inc. · 2009
  9. Descendant · 2 generations on · 1 of its ownK162348 ABCcolla Collagen MatrixAcro Biomedical Co., Ltd. · 2017
  10. Descendant · 3 generations on · 0 of its ownK233378 ABCcolla® Collagen ADM ScaffoldAcro Biomedical Co., Ltd. · 2024

Most influential descendants

Showing 3 of 3 · See all
  • K090894Collawound Wound DressingCollamatrix Co., Inc. · 2009 · cites it directly2descendants
  • K162348ABCcolla Collagen MatrixAcro Biomedical Co., Ltd. · 2017 · 2 generations on1descendant
  • K233378ABCcolla® Collagen ADM ScaffoldAcro Biomedical Co., Ltd. · 2024 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−6K921895Tissue Patch, Tissue GraftBio-Vascular, Inc.1992—
−5K961810Supple Peri-Guard PericardiumBio-Vascular, Inc.1996—
−4K980431SurgisisCook Biotech, Inc.1998—
−3K992159Surgisis SlingCook Biotech, Inc.1999—
−2K001738Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc.2000—
−1K021637Acell Ubm Lyophilized Wound DressingAcell, Inc.2002—
0 (this device)K061474Collawound DressingCollamatrix Co., Inc.2006—
+1K090894Collawound Wound DressingCollamatrix Co., Inc.2009—
+2K162348ABCcolla Collagen MatrixAcro Biomedical Co., Ltd.2017—
+3K233378ABCcolla® Collagen ADM ScaffoldAcro Biomedical Co., Ltd.2024—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198310
198510
198810
199130
199210
199310
199410
199630
199710
199850
199910
200010
200120
200210
200310

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
201710
202410
FIG. 1 — Lineage of K061474, 1992–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K021637Acell Ubm Lyophilized Wound Dressing
Summary page 2
…ological characteristics and intended use to predicate collagen-based devices that are previously approved by the agency: ACell UBM Lyophilized wound dressing (K021637), Fortaderm (KO1 1026), SS Matrix (K020732), Collagen topical wound dressing (K030921), Collatek powder (K012990) and M…
Acell, Inc.2002—
*K011026Fortaderm Wound DressingOrganogenesis, Inc.2001—
*K020732SS Matrix
Summary page 2
…o predicate collagen-based devices that are previously approved by the agency: ACell UBM Lyophilized wound dressing (K021637), Fortaderm (KO1 1026), SS Matrix (K020732), Collagen topical wound dressing (K030921), Collatek powder (K012990) and Medifil (K910944). 9. Safety Biocompatib…
Cook Biotech, Inc.2002—
*K030921Collagen Topical Wound Dressing
Summary page 2
…previously approved by the agency: ACell UBM Lyophilized wound dressing (K021637), Fortaderm (KO1 1026), SS Matrix (K020732), Collagen topical wound dressing (K030921), Collatek powder (K012990) and Medifil (K910944). 9. Safety Biocompatibility tests have confirmed that CollaWound…
Collagen Matrix, Inc.2003—
*K012990Collatek Powder
Summary page 2
…agency: ACell UBM Lyophilized wound dressing (K021637), Fortaderm (KO1 1026), SS Matrix (K020732), Collagen topical wound dressing (K030921), Collatek powder (K012990) and Medifil (K910944). 9. Safety Biocompatibility tests have confirmed that CollaWound TM dressing meets the requiremen…
Biocore Medical Technologies, Inc.2001—
*K910944Medifil
Summary page 2
…philized wound dressing (K021637), Fortaderm (KO1 1026), SS Matrix (K020732), Collagen topical wound dressing (K030921), Collatek powder (K012990) and Medifil (K910944). 9. Safety Biocompatibility tests have confirmed that CollaWound TM dressing meets the requirements stated in ISO…
Biocore1991—

Also cleared against K021637: 4 other devices →

What descends from it? (3)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K090894Collawound Wound DressingCollamatrix Co., Inc.20092

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 5 companies; a new generation was cleared every 2.0 years on median.
  • 2 of the 30 ancestors have a recall of any class.
  • Of its descendants, K090894 (Collamatrix Co., Inc., 2009) has gone furthest, with 2 descendants of its own.
  • 4 other devices also cite its predicate K021637.

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?

CollaWound TM dressing is intended for the management of partial and full-thickness exudating wounds including:

- Pressure ulcers

- Venous ulcers

- Vascular ulcers

- Diabetic ulcers

- Trauma wounds (abrasions, lacerations, skin tears)

- First and second degree bums

- Surgical wounds

Indications for use as stated in the FDA summary.

Also cleared against K021637

4 other devices cite the same predicate.

  • K092096Endoform Dermal TemplateMesynthes, Ltd. · 20103 recalls
  • K092926Acell Matristem Wound SheetAcell, Inc. · 2009
  • K060888Acell Powder Wound DressingAcell, Inc. · 2006
  • K040621Acell Ubm Surgical MeshAcell, Inc. · 2004

More from Collamatrix Co., Inc.

4 FDA decisions under this applicant name. See the company

  • K090894Collawound Wound DressingCollamatrix Co., Inc. · 2009
  • K071557Collawound HydrogelCollamatrix Co., Inc. · 2008
  • K070269Modification to Collawound DressingCollamatrix Co., Inc. · 2007

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/K061474 · printed Nov 6, 2026

Cite this page

510(k) Report. “K061474: Collawound Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061474

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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