# K102478: Otc Elasto-Gel Manuka Honey Wound Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Southwest Technologies, Inc.
- Decided: Nov 3, 2010 after 65 days
- Product code: FRO (Dressing, Wound, Drug)
- 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 K053095 (2007). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K872165: Elasto-Gel Occlusive Dressing, Southwest Technologies, Inc. (1987) Summary page 1.
- K083334: Elasto-Gel Manuka Honey Wound Dressing, Southwest Technologies, Inc. (2009) Summary page 1.
- K053095: Honey Alginate Dressing, Derma Sciences Canada, Inc. (2007) Summary page 1.
- K072956: Medihoney Primary Dressings with Active Manuka Honey, Derma Sciences, Inc. (2007) Summary page 1.

## Most influential descendants
- K101114: Advancis Activon Tube (2011), 0 descendants of its own

## Indications for use
The OTC Manuka Honey Wound Dressing is indicated far minor cuts, minor abrasions, minor scalds and minor burns.

Source page: https://510kreport.com/device/K102478
Methodology: https://510kreport.com/methodology