510(k) · Cleared
ClearedCollaguard, Model Fcia,Fcib,Fcic,and Fcid
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Innocoll Pharmaceuticals · KGN Wound Dressing With Animal-Derived Material (S)
Cleared on Oct 2, 2006 as substantially equivalent to K040558 (Collagen Matrix, Inc., 2004) after a 103-day review. Its family tree reaches back 4 generations to 1991. 12 later devices descend from it.
- Decided
- Oct 2, 2006
- Review
- 103 days
- Class
- Class U
- Product code
- KGN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K910944 (1991). 7 ancestors in all. 12 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK910944 MedifilBiocore · 1991
- 3 generations backK030921 Collagen Topical Wound DressingCollagen Matrix, Inc. · 2003
- 2 generations backK040211 Modification to: Collagen Topical Wound DressingCollagen Matrix, Inc. · 2004
- 1 generation backK040558 Modification to: Collagen Topical Wound DressingCollagen Matrix, Inc. · 2004
- This deviceK061746 Collaguard, Model Fcia,Fcib,Fcic,and FcidInnocoll Pharmaceuticals · 2006
- Descendant · cites it directly · 11 of its ownK081782 CollievaInnocoll Pharmaceuticals · 2008
- Descendant · cites it directly · 10 of its ownK092805 Collagen SpongeInnocoll Pharmaceuticals · 2010
- Descendant · 2 generations on · 6 of its ownK110388 Collacare DentalInnocoll Pharmaceuticals, Ltd. · 2011
- Descendant · 3 generations on · 5 of its ownK122115 Collagen Dental Wound DressingsCollagen Matrix, Inc. · 2012
- Descendant · 4 generations on · 2 of its ownK152600 Collagen Dental Wound DressingsCollagen Matrix, Inc. · 2016 · Recalled
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K081782CollievaInnocoll Pharmaceuticals · 2008 · cites it directly11descendants
- K092805Collagen SpongeInnocoll Pharmaceuticals · 2010 · cites it directly10descendants
- K110388Collacare DentalInnocoll Pharmaceuticals, Ltd. · 2011 · 2 generations on6descendants
- K122115Collagen Dental Wound DressingsCollagen Matrix, Inc. · 2012 · 3 generations on5descendants
- K152600Collagen Dental Wound DressingsCollagen Matrix, Inc. · 2016 · 4 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K910944 | Medifil | Biocore | 1991 | — |
| −3 | K030921 | Collagen Topical Wound Dressing | Collagen Matrix, Inc. | 2003 | — |
| −2 | K040211 | Modification to: Collagen Topical Wound Dressing | Collagen Matrix, Inc. | 2004 | — |
| −1 | K040558 | Modification to: Collagen Topical Wound Dressing | Collagen Matrix, Inc. | 2004 | — |
| 0 (this device) | K061746 | Collaguard, Model Fcia,Fcib,Fcic,and Fcid | Innocoll Pharmaceuticals | 2006 | — |
| +1 | K081782 | Collieva | Innocoll Pharmaceuticals | 2008 | — |
| +1 | K092805 | Collagen Sponge | Innocoll Pharmaceuticals | 2010 | — |
| +2 | K110388 | Collacare Dental | Innocoll Pharmaceuticals, Ltd. | 2011 | — |
| +3 | K122115 | Collagen Dental Wound Dressings | Collagen Matrix, Inc. | 2012 | — |
| +4 | K152600 | Collagen Dental Wound Dressings | Collagen Matrix, Inc. | 2016 | 1 |
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 |
|---|---|---|
| 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? (1)
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 |
|---|---|---|---|
| * | K040558 | Modification to: Collagen Topical Wound DressingSummary page 1…l Equivalence: CollaGUARD TM is substantially equivalent in materials of construction and intended use to Collagen Topical Wound Dressing (K040558) manufactured by Collagen Matrix Inc. Directors: Michael Myers, Denise Carter, Joan FitzPatrick Company Regi… | 2004 |
What descends from it? (12)
See all 122 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 15 years and passes through 3 companies; a new generation was cleared every 2.5 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K081782 (Innocoll Pharmaceuticals, 2008) has gone furthest, with 11 descendants of its own.
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?
CollaGUARD may be used for the management of wounds such as:
* Pressure ulcers
* Venous stasis ulcers
* Diabetic ulcers
* First and second degree burns
* Partial and full thickness wounds
* Superficial injuries
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061746 · printed Nov 5, 2026
Cite this page
510(k) Report. “K061746: Collaguard, Model Fcia,Fcib,Fcic,and Fcid.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K061746
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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