510(k) · Cleared
ClearedCollagen Wound Dressing - Oral
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 10, 2004 as substantially equivalent to K994339 (The Hymed Group Corp., 2000) and 1 other predicate after an 83-day review. Its family tree reaches back 2 generations to 1991. 10 later devices descend from it.
- Decided
- May 10, 2004
- Review
- 83 days
- Class
- Class U
- Product code
- KGN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K910944 (1991). 6 ancestors in all. 10 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK910944 MedifilBiocore · 1991
- 1 generation backK030921 Collagen Topical Wound DressingCollagen Matrix, Inc. · 2003
- This deviceK040403 Collagen Wound Dressing - OralCollagen Matrix, Inc. · 2004
- Descendant · cites it directly · 6 of its ownK110388 Collacare DentalInnocoll Pharmaceuticals, Ltd. · 2011
- Descendant · cites it directly · 5 of its ownK122115 Collagen Dental Wound DressingsCollagen Matrix, Inc. · 2012
- Descendant · 2 generations on · 2 of its ownK152600 Collagen Dental Wound DressingsCollagen Matrix, Inc. · 2016 · Recalled
- Descendant · 2 generations on · 1 of its ownK133290 Collacare DentalInnocoll Pharmaceuticals · 2014
- Descendant · cites it directly · 1 of its ownK080868 Aongen Collagen MatrixAeon Astron Europe B.V. · 2009
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K110388Collacare DentalInnocoll Pharmaceuticals, Ltd. · 2011 · cites it directly6descendants
- K122115Collagen Dental Wound DressingsCollagen Matrix, Inc. · 2012 · cites it directly5descendants
- K152600Collagen Dental Wound DressingsCollagen Matrix, Inc. · 2016 · 2 generations on2descendants
- K133290Collacare DentalInnocoll Pharmaceuticals · 2014 · 2 generations on1descendant
- K080868Aongen Collagen MatrixAeon Astron Europe B.V. · 2009 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K910944 | Medifil | Biocore | 1991 | — |
| −1 | K030921 | Collagen Topical Wound Dressing | Collagen Matrix, Inc. | 2003 | — |
| 0 (this device) | K040403 | Collagen Wound Dressing - Oral | Collagen Matrix, Inc. | 2004 | — |
| +1 | K110388 | Collacare Dental | Innocoll Pharmaceuticals, Ltd. | 2011 | — |
| +1 | K122115 | Collagen Dental Wound Dressings | Collagen Matrix, Inc. | 2012 | — |
| +2 | K152600 | Collagen Dental Wound Dressings | Collagen Matrix, Inc. | 2016 | 1 |
| +2 | K133290 | Collacare Dental | Innocoll Pharmaceuticals | 2014 | — |
| +1 | K080868 | Aongen Collagen Matrix | Aeon Astron Europe B.V. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 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 |
|---|---|---|---|
| * | K994339 | Hycure Oral / Hycure Oral Smart GelSummary page 1…d 880.5090 KMF Predicate Device(s): hyCure® Oral, The Hymed Group Corp, K994339 Collagen Topical Wound Dressing, Collagen Matrix,… | 2000 |
| * | K030921 | Collagen Topical Wound DressingSummary page 1…al, The Hymed Group Corp, K994339 Collagen Topical Wound Dressing, Collagen Matrix, Inc., K030921 Description of the Device Collagen Wound Dressing - Oral is a white to off-white, absorbent, microfibrillar coll… | 2003 |
What descends from it? (10)
4 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 13 years and passes through 2 companies; a new generation was cleared every 12.1 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K110388 (Innocoll Pharmaceuticals, Ltd., 2011) has gone furthest, with 6 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?
Collagn Wound Dressing - Oral is indicated for the management of oral wounds and sores, including:
· Denture sores
* Oral ulcers (non-infected or viral)
· Periodontal surgical wounds
· Suture sites
· Bums
· Extraction sites
· Surgical wounds
· Traumatic wounds
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040403 · printed Nov 3, 2026
Cite this page
510(k) Report. “K040403: Collagen Wound Dressing - Oral.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K040403
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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