# K130857: Prontosan Wound Gel X

- Pathway: 510(k) (Traditional)
- Applicant: B.Braun Medical, Inc.
- Decided: Oct 8, 2013 after 194 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: 5 generations back to K914604 (1992). 14 ancestors in all.
3 later devices descend from it; 2 cite 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)
- K062212: Silver Shield Antimicrobial Skin and Wound Gel, Model 3015-S, Anacapa Technologies, Inc. (2006) Summary page 5.
- K121522: Polyfit Absorbing Antimicrobial Dressings (Otc), Polyremedy, Inc. (2012) Summary page 5.

## Most influential descendants
- K192527: Rochal Antimicrobial Wound Gel (2020), 2 descendants of its own
- 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
Rx: Prontosan® Wound Gel X is indicated for the management of ulcers (including diabetic foot and leg ulcers and pressure ulcers), 1¥ and 2™ degree burns, partial and full thickness wounds, large surface area wounds and surgical incisions. OTC: Prontosan Wound Gel X is indicated for the management minor cuts, minor lacerations, minor bumns (1" degree burns), and abrasions.

Source page: https://510kreport.com/device/K130857
Methodology: https://510kreport.com/methodology