510(k) · Cleared
ClearedModification to: Collagen 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 Mar 17, 2004 as substantially equivalent to K030921 (Collagen Matrix, Inc., 2003) and 1 other predicate after a 14-day review. Its family tree reaches back 3 generations to 1991. 13 later devices descend from it.
- Decided
- Mar 17, 2004
- Review
- 14 days
- Class
- Class U
- Product code
- KGN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K910944 (1991). 6 ancestors in all. 13 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK910944 MedifilBiocore · 1991
- 2 generations backK030921 Collagen Topical Wound DressingCollagen Matrix, Inc. · 2003
- 1 generation backK040211 Modification to: Collagen Topical Wound DressingCollagen Matrix, Inc. · 2004
- This deviceK040558 Modification to: Collagen Topical Wound DressingCollagen Matrix, Inc. · 2004
- Descendant · cites it directly · 12 of its ownK061746 Collaguard, Model Fcia,Fcib,Fcic,and FcidInnocoll Pharmaceuticals · 2006
- Descendant · 2 generations on · 11 of its ownK081782 CollievaInnocoll Pharmaceuticals · 2008
- Descendant · 2 generations on · 10 of its ownK092805 Collagen SpongeInnocoll Pharmaceuticals · 2010
- Descendant · 3 generations on · 6 of its ownK110388 Collacare DentalInnocoll Pharmaceuticals, Ltd. · 2011
- Descendant · 4 generations on · 5 of its ownK122115 Collagen Dental Wound DressingsCollagen Matrix, Inc. · 2012
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K061746Collaguard, Model Fcia,Fcib,Fcic,and FcidInnocoll Pharmaceuticals · 2006 · cites it directly12descendants
- K081782CollievaInnocoll Pharmaceuticals · 2008 · 2 generations on11descendants
- K092805Collagen SpongeInnocoll Pharmaceuticals · 2010 · 2 generations on10descendants
- K110388Collacare DentalInnocoll Pharmaceuticals, Ltd. · 2011 · 3 generations on6descendants
- K122115Collagen Dental Wound DressingsCollagen Matrix, Inc. · 2012 · 4 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K910944 | Medifil | Biocore | 1991 | — |
| −2 | K030921 | Collagen Topical Wound Dressing | Collagen Matrix, Inc. | 2003 | — |
| −1 | K040211 | Modification to: Collagen Topical Wound Dressing | Collagen Matrix, Inc. | 2004 | — |
| 0 (this device) | K040558 | Modification to: Collagen Topical Wound Dressing | Collagen Matrix, Inc. | 2004 | — |
| +1 | K061746 | Collaguard, Model Fcia,Fcib,Fcic,and Fcid | Innocoll Pharmaceuticals | 2006 | — |
| +2 | K081782 | Collieva | Innocoll Pharmaceuticals | 2008 | — |
| +2 | K092805 | Collagen Sponge | Innocoll Pharmaceuticals | 2010 | — |
| +3 | K110388 | Collacare Dental | Innocoll Pharmaceuticals, Ltd. | 2011 | — |
| +4 | K122115 | Collagen Dental Wound Dressings | Collagen Matrix, Inc. | 2012 | — |
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 |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K030921 | Collagen Topical Wound DressingSummary page 1…und, Collagen Unclassified KGN Predicate Device(s): Collagen Topical Wound Dressing, K030921 Collagen Topical Wound Dressing, K0402 11 Description of the Device Collagen Topical Woun… | 2003 |
| * | K040211 | Modification to: Collagen Topical Wound DressingSummary page 1…KGN Predicate Device(s): Collagen Topical Wound Dressing, K030921 Collagen Topical Wound Dressing, K0402 11 Description of the Device Collagen Topical Wound Dressing is an opaque, absorbent, collagen membrane matrix intended for to… | 2004 |
What descends from it? (13)
See all 131 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K061746 | Collaguard, Model Fcia,Fcib,Fcic,and Fcid | 2006 | 12 |
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 13 years and passes through 2 companies; a new generation was cleared every 9 months on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K061746 (Innocoll Pharmaceuticals, 2006) has gone furthest, with 12 descendants of its own.
- 6 other devices also cite its predicate K030921.
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 burns
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040558 · printed Nov 3, 2026
Cite this page
510(k) Report. “K040558: Modification to: Collagen Topical Wound Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K040558
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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