# K092086: Amerigel Wound Dressing Plus 1/2 OZ. (15G Tube), Model A2025; 1 OZ. (30G Tube), Model A2026; 3 OZ (90G Tube),Model A2027

- Pathway: 510(k) (Traditional)
- Applicant: Amerx Health Care Corp.
- Decided: Jul 30, 2009 after 21 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: 3 generations back to K952276 (1995). 3 ancestors in all.
6 later devices descend from it; 4 cite 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)
- K020540: Regenecare Wound Gel, Mpm Medical., Inc. (2002) Summary page 1.

## Cited in the summary but kept off the family tree
- K002136: AmeriGel Wound Dressing. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1.

## Most influential descendants
- 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
- K211943: Microlyte Ag/Lidocaine (2024), 0 descendants of its own

## Indications for use
Stage I - IV Pressure ulcers Venous stasis ulcers. Ulcerations caused by mixed vascular etiologies Diabetic skin ulcers First and second degree burns Post-surgical incisions Cuts and abrasions

Source page: https://510kreport.com/device/K092086
Methodology: https://510kreport.com/methodology