# K872165: Elasto-Gel Occlusive Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Southwest Technologies, Inc.
- Decided: Jun 26, 1987 after 21 days
- Product code: FRO (Dressing, Wound, Drug)
- Device class: U
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
9 later devices descend from it; 3 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)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K083334: Elasto-Gel Manuka Honey Wound Dressing (2009), 5 descendants of its own
- K053613: L-Mesitran Hydro, L-Mesitran Border, L-Mesitran Net, L-Mesitran Active (2007), 3 descendants of its own
- K182725: Apis (2019), 2 descendants of its own
- K110546: Medihoney Hydrogel Sheet Dressings with Active Leptospermum Honey (2011), 1 descendant of its own
- K102478: Otc Elasto-Gel Manuka Honey Wound Dressing (2010), 1 descendant of its own

## Recalls of this device
- Nov 18, 2019 · Class II · Z-0687-2020: Elasto-Gel Wound Dressing may be contaminated with mold.
- Mar 27, 2006 · Not classified · Z-0841-06: The product is labeled as sterile and one of the lots failed sterility during the quarterly radiation dose audit.

Source page: https://510kreport.com/device/K872165
Methodology: https://510kreport.com/methodology