# K082103: LTM Wound Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Lifecell Corp.
- Decided: Oct 8, 2008 after 75 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: 6 generations back to K921895 (1992). 35 ancestors in all.
7 later devices descend from it; 2 cite it directly.
0 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071425: Unite Biomatrix, Pegasus Biologics, Inc. (2007) Summary page 1.
- K070560: LRTM Surgical Mesh, Lifecell Corp. (2007) Summary page 1.

## Most influential descendants
- K132343: Marigen Wound Dressing (2013), 5 descendants of its own
- K190528: MariGen Wound Extra (2019), 3 descendants of its own
- K241080: Kerecis Parvus (50207) (2024), 1 descendant of its own
- K213231: Kerecis Silicone (2022), 1 descendant of its own
- K251845: Marigen Wound Extra; Kerecis Silicone; Kerecis Parvus (2025), 0 descendants of its own

## Indications for use
The LTM Wound Dressing is intended for the management of wounds including: - Partial and full thickness wounds; - Pressure ulcers; - Venous ulcers; - Diabetic ulcers; - Chronic vascular ulcers; - Tunneled/undermined wounds; - Surgical wounds (donor sites/grafts, post-Moh's surgery, post laser surgery, podiatric, wound dehiscence); - Trauma wounds (abrasions, lacerations, second-degree burns and skin tears); - Draining wounds - And other bleeding surface wounds. The LTM Wound Dressing provides an environment that supports wound healing and control of minor bleeding. The device is intended for single patient, one time use only.

Source page: https://510kreport.com/device/K082103
Methodology: https://510kreport.com/methodology