# K030774: Stimulen Collagen

- Pathway: 510(k) (Traditional)
- Applicant: Southwest Technologies, Inc.
- Decided: Aug 9, 2004 after 517 days
- Product code: KGN (Wound Dressing With Animal-Derived Material(S))
- Device class: U
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K910944 (1991). 4 ancestors in all.
29 later devices descend from it; 3 cite it directly.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K910944: Medifil, Biocore (1991) Summary page 1.
- K955506: Hycure, The Hymed Group Corp. (1996) Summary page 1.
- K012990: Collatek Powder, Biocore Medical Technologies, Inc. (2001) Summary page 1.
- K990086: Heliderm Collagen Wound Dressings 0.5 Gram and 1.0 Gram, Integra Lifesciences Corp. (1999) Summary page 1.

## Most influential descendants
- K061494: Dermadapt Wound Dressing (2006), 26 descendants of its own
- K071425: Unite Biomatrix (2007), 25 descendants of its own
- K092096: Endoform Dermal Template (2010), 19 descendants of its own
- K082103: LTM Wound Dressing (2008), 7 descendants of its own
- K132343: Marigen Wound Dressing (2013), 5 descendants of its own

## Recalls of this device
- May 28, 2021 · Class II · Z-2109-2021: Dose audit failure after sterilization process

## Indications for use
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

Source page: https://510kreport.com/device/K030774
Methodology: https://510kreport.com/methodology