# K990086: Heliderm Collagen Wound Dressings 0.5 Gram and 1.0 Gram

- Pathway: 510(k) (Traditional)
- Applicant: Integra Lifesciences Corp.
- Decided: Mar 31, 1999 after 79 days
- Product code: KGN (Wound Dressing With Animal-Derived Material(S))
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
85 later devices descend from it; 8 cite it directly.
0 of 86 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) hycure®: named in the summary without a submission number
- (no number) Fibracol: named in the summary without a submission number
- (no number) Kaltostat® Wound Packing: named in the summary without a submission number
- (no number) Chronicure: named in the summary without a submission number
- (no number) VitaChoice: named in the summary without a submission number

## Most influential descendants
- K030774: Stimulen Collagen (2004), 29 descendants of its own
- K040283: Biopad (2005), 28 descendants of its own
- K030921: Collagen Topical Wound Dressing (2003), 28 descendants of its own
- K061494: Dermadapt Wound Dressing (2006), 26 descendants of its own
- K071425: Unite Biomatrix (2007), 25 descendants of its own

## Indications for use
HeliDerm™ Collagen Wound Dressing is indicated for the management of moderately to heavily exudating wounds, and to control minor bleeding. HeliDerm™ may be used for the management of exudating wounds such as: e PRESSURE ULCERS e VENOUS STASIS ULCERS e DIABETIC ULCERS e ACUTE WOUNDS, for example trauma and surgical wounds e PARTIAL-THICKNESS BURNS

Source page: https://510kreport.com/device/K990086
Methodology: https://510kreport.com/methodology