# K020540: Regenecare Wound Gel

- Pathway: 510(k) (Traditional)
- Applicant: Mpm Medical., Inc.
- Decided: Nov 1, 2002 after 255 days
- Product code: SEJ (Wound Dressings Containing Topical Analgesics)
- 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 K952276 (1995). 2 ancestors in all.
7 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992074: MPM Regenecare Wound Gel, Mpm Medical., Inc. (1999) Summary page 1.

## Most influential descendants
- K092086: Amerigel Wound Dressing Plus 1/2 OZ. (15G Tube), Model A2025; 1 OZ. (30G Tube), Model A2026; 3 OZ (90G Tube),Model A2027 (2009), 6 descendants of its own
- K150792: Next Science Wound Gel (2015), 2 descendants of its own
- K163188: Next Science Wound Gel (Rx) (2017), 1 descendant of its own
- K254191: IWD-Gel™ (2026), 0 descendants of its own
- K252028: LUOFUCON® Antimicrobial Wound Gel (2026), 0 descendants of its own

## Indications for use
Local management of skin wounds, including pressure ulcers, venous stasis ulcers, first and second degree burns, and superficial wounds and scrapes.

Source page: https://510kreport.com/device/K020540
Methodology: https://510kreport.com/methodology