# K192527: Rochal Antimicrobial Wound Gel

- Pathway: 510(k) (Traditional)
- Applicant: Rochal Industries, LLC
- Decided: Feb 7, 2020 after 147 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: 6 generations back to K914604 (1992). 15 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130857: Prontosan Wound Gel X, B.Braun Medical, Inc. (2013) Summary page 7.

## Most influential descendants
- K223259: coactiv+™ Antimicrobial Wound Gel (2023), 1 descendant of its own
- K241809: coactiv+™ Antimicrobial Wound Gel (2024), 0 descendants of its own

## Indications for use
ROCHAL Antimicrobial Wound Gel is intended for the management of ulcers (including diabetic foot and leg ulcers and pressure ulcers), first- and second-degree burns, partial- and full-thickness wounds, large surface area wounds, and surgical incisions. ROCHAL Antimicrobial Wound Gel is intended for the management of minor skin scrapes, minor cuts, minor lacerations, minor burns (1st degree burns), minor irritations.

Source page: https://510kreport.com/device/K192527
Methodology: https://510kreport.com/methodology