# K014129: Promogran Matrix Wound Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Johnson & Johnson Medical, Ltd.
- Decided: Feb 14, 2002 after 59 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
Longest line of descent: 2 generations back to K881854 (1988). 4 ancestors in all.
77 later devices descend from it; 6 cite it directly.
0 of 82 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982597: Fibrcol Plus Collagen Wound Dressing with Alginate, Johnson & Johnson Medical, Inc. (1998) Summary page 5.

## Most influential descendants
- K021792: Bilayer Matrix Wound Dressing (2002), 53 descendants of its own
- K022127: Avagen Wound Dressing (2002), 28 descendants of its own
- K092096: Endoform Dermal Template (2010), 19 descendants of its own
- K132397: Gore Bio-a Wound Matrix (2014), 10 descendants of its own
- K081635: Integra Meshed Bilayer Wound Matrix (2008), 10 descendants of its own

## Indications for use
PROMOGRAN Matrix Wound Dressing is intended for the management of exuding wounds including: Diabetic ulcers Venous ulcers Pressure ulcers Ulcers caused by mixed vascular etiologies Full thickness and partial thickness wounds Donor sites and other bleeding surface wounds Abrasions Traumatic wounds healing by secondary intention Dehisced surgical wounds

Source page: https://510kreport.com/device/K014129
Methodology: https://510kreport.com/methodology