510(k) · Cleared
ClearedCollagen Topical Wound Dressing
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Collagen Matrix, Inc. · KGN Wound Dressing With Animal-Derived Material (S)
Cleared on May 15, 2003 as substantially equivalent to K910944 (Biocore, 1991) and 3 other predicates after a 52-day review. Its family tree reaches back 1 generation to 1991. 28 later devices descend from it.
- Decided
- May 15, 2003
- Review
- 52 days
- Class
- Class U
- Product code
- KGN
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 1 generation to K910944 (1991). 4 ancestors in all. 28 later devices descend from it, 7 citing it directly.
- Root · 1 generation backK910944 MedifilBiocore · 1991
- This deviceK030921 Collagen Topical Wound DressingCollagen Matrix, Inc. · 2003
- Descendant · cites it directly · 14 of its ownK040211 Modification to: Collagen Topical Wound DressingCollagen Matrix, Inc. · 2004
- Descendant · cites it directly · 13 of its ownK040558 Modification to: Collagen Topical Wound DressingCollagen Matrix, Inc. · 2004
- Descendant · 2 generations on · 12 of its ownK061746 Collaguard, Model Fcia,Fcib,Fcic,and FcidInnocoll Pharmaceuticals · 2006
- Descendant · 3 generations on · 11 of its ownK081782 CollievaInnocoll Pharmaceuticals · 2008
- Descendant · 3 generations on · 10 of its ownK092805 Collagen SpongeInnocoll Pharmaceuticals · 2010
Showing 5 of 28 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 28 · See all- K040211Modification to: Collagen Topical Wound DressingCollagen Matrix, Inc. · 2004 · cites it directly14descendants
- K040558Modification to: Collagen Topical Wound DressingCollagen Matrix, Inc. · 2004 · cites it directly13descendants
- K061746Collaguard, Model Fcia,Fcib,Fcic,and FcidInnocoll Pharmaceuticals · 2006 · 2 generations on12descendants
- K081782CollievaInnocoll Pharmaceuticals · 2008 · 3 generations on11descendants
- K092805Collagen SpongeInnocoll Pharmaceuticals · 2010 · 3 generations on10descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K910944 | Medifil | Biocore | 1991 | — |
| 0 (this device) | K030921 | Collagen Topical Wound Dressing | Collagen Matrix, Inc. | 2003 | — |
| +1 | K040211 | Modification to: Collagen Topical Wound Dressing | Collagen Matrix, Inc. | 2004 | — |
| +1 | K040558 | Modification to: Collagen Topical Wound Dressing | Collagen Matrix, Inc. | 2004 | — |
| +2 | K061746 | Collaguard, Model Fcia,Fcib,Fcic,and Fcid | Innocoll Pharmaceuticals | 2006 | — |
| +3 | K081782 | Collieva | Innocoll Pharmaceuticals | 2008 | — |
| +3 | K092805 | Collagen Sponge | Innocoll Pharmaceuticals | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 3 | 0 |
| 2006 | 3 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 3 | 0 |
| 2025 | 1 | 0 |
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
What was it cleared against? (5)
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 | Decided |
|---|---|---|---|
| * | K910944 | MedifilSummary page 1…Class I 880.5090 KMF Prcdicatc Dcvice(s): MedifiI@Kollagen Particles, IC910944 Collatck@Powder, KO12990 HeliDemTMCollagcn Wound Dressing, K9… | 1991 |
| * | K012990 | Collatek Powder | 2001 |
| * | K990086 | Heliderm Collagen Wound Dressings 0.5 Gram and 1.0 GramSummary page 1…MedifiI@Kollagen Particles, IC910944 Collatck@Powder, KO12990 HeliDemTMCollagcn Wound Dressing, K990086 hyCurc@Advanced Collagen Wound Care, US5506 FIBRACOLTMCollage… | 1999 |
| * | K925548 | Fibracol Collagen-Alginate DressingSummary page 1…d Dressing, K990086 hyCurc@Advanced Collagen Wound Care, US5506 FIBRACOLTMCollagen-Alginate Dressjng, K925548 Dcscription of the Device Thc Collagen Topical Wound Dressing is a white to off-whitc, absorbent, microfibrilla particulate col… | 1993 |
| * | — | hyCure Advanced Collagen Wound Care Named without a submission number |
What descends from it? (28)
See all 287 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K040211 | Modification to: Collagen Topical Wound Dressing | 2004 | 14 |
| K040558 | Modification to: Collagen Topical Wound Dressing | 2004 | 13 |
| K040403 | Collagen Wound Dressing - Oral | 2004 | 10 |
| K060888 | Acell Powder Wound Dressing | 2006 | 5 |
| K061474 | Collawound Dressing | 2006 | 3 |
| K080868 | Aongen Collagen Matrix | 2009 | 1 |
| K213341 | Fibrillar Collagen Wound Dressing | 2022 | 0 |
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?
How does its category compare?
All KGN devicesKGN 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
2026 to Oct 25, outlined.
Median 510(k) review, days · KGN
162in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KGN
3in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KGN
15in 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?
Collagen Topical Wound Dressing is indicated for the management of moderately to heavily exudating wounds and to control minor bleeding.
Collagen Topical Wound Dressing may be used for the management of exudating wounds such as:
Pressure ulcers
Venous stasis ulcers
Diabetic ulcers
Acute wounds, for example trauma and surgical wounds
Partial-thickness bums
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030921 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030921: Collagen Topical Wound Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030921
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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