510(k) · Cleared
Recalled · Class II · 2021Stimulen Collagen
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Southwest Technologies, Inc. · KGN Wound Dressing With Animal-Derived Material (S)
Cleared on Aug 9, 2004 as substantially equivalent to K910944 (Biocore, 1991) and 3 other predicates after a 517-day review. Its family tree reaches back 1 generation to 1991. 29 later devices descend from it. It has been recalled once.
- Decided
- Aug 9, 2004
- Review
- 517 days
- Class
- Class U
- Product code
- KGN
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 1 generation to K910944 (1991). 4 ancestors in all. 29 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK910944 MedifilBiocore · 1991
- This deviceK030774 Stimulen CollagenSouthwest Technologies, Inc. · 2004
- Descendant · cites it directly · 26 of its ownK061494 Dermadapt Wound DressingPegasus Biologics, Inc. · 2006
- Descendant · 2 generations on · 25 of its ownK071425 Unite BiomatrixPegasus Biologics, Inc. · 2007
- Descendant · 3 generations on · 19 of its ownK092096 Endoform Dermal TemplateMesynthes, Ltd. · 2010 · Recalled
- Descendant · 3 generations on · 7 of its ownK082103 LTM Wound DressingLifecell Corp. · 2008
- Descendant · 4 generations on · 5 of its ownK132343 Marigen Wound DressingKerecis Limited · 2013
Showing 5 of 29 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 29 · See all- K061494Dermadapt Wound DressingPegasus Biologics, Inc. · 2006 · cites it directly26descendants
- K071425Unite BiomatrixPegasus Biologics, Inc. · 2007 · 2 generations on25descendants
- K092096Endoform Dermal TemplateMesynthes, Ltd. · 2010 · 3 generations on19descendants
- K082103LTM Wound DressingLifecell Corp. · 2008 · 3 generations on7descendants
- K132343Marigen Wound DressingKerecis Limited · 2013 · 4 generations on5descendants
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) | K030774 | Stimulen Collagen | Southwest Technologies, Inc. | 2004 | — |
| +1 | K061494 | Dermadapt Wound Dressing | Pegasus Biologics, Inc. | 2006 | — |
| +2 | K071425 | Unite Biomatrix | Pegasus Biologics, Inc. | 2007 | — |
| +3 | K092096 | Endoform Dermal Template | Mesynthes, Ltd. | 2010 | 3 |
| +3 | K082103 | LTM Wound Dressing | Lifecell Corp. | 2008 | — |
| +4 | K132343 | Marigen Wound Dressing | Kerecis Limited | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 3 | 0 |
| 2025 | 3 | 0 |
| 2026 | 5 | 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? (4)
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…Inc. 1746 Levee Road N. Kansas City, MO. 64116 Substantial Equivalence Claim MedifilTM by BioCore (K 910944) hyCuret m by Hyrned Group (K955506) CollatekTM by BioCore (K0 12990) HeliD… | 1991 |
| * | K955506 | HycureSummary page 1…N. Kansas City, MO. 64116 Substantial Equivalence Claim MedifilTM by BioCore (K 910944) hyCuret m by Hyrned Group (K955506) CollatekTM by BioCore (K0 12990) HeliDermif" by Integra (K990086) Device Des… | 1996 |
| * | K012990 | Collatek PowderSummary page 1…antial Equivalence Claim MedifilTM by BioCore (K 910944) hyCuret m by Hyrned Group (K955506) CollatekTM by BioCore (K0 12990) HeliDermif" by Integra (K990086) Device Description… | 2001 |
| * | K990086 | Heliderm Collagen Wound Dressings 0.5 Gram and 1.0 GramSummary page 1…by BioCore (K 910944) hyCuret m by Hyrned Group (K955506) CollatekTM by BioCore (K0 12990) HeliDermif" by Integra (K990086) Device Description… | 1999 |
What descends from it? (29)
See all 293 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 28, 2021 | Class II | Z-2109-2021 | Under Investigation by firm | Dose audit failure after sterilization process |
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?
Stimulen Collagen is indicated for prolonged use (24 hr to 30 days) in the management of wounds including:
full and partial thickness wounds
pressure ulcers (stages I-IV)
venous stasis ulcers
diabetic ulcers
partial thickness burns
acute wounds
abrasions
traumatic wounds healing by secondary intention
donor sites and other surface wounds
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030774 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030774: Stimulen Collagen.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030774
Report an extraction error
Are you the manufacturer?
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