# K110744: Prontosan Wound Irrigation Solution

- Pathway: 510(k) (Traditional)
- Applicant: B.Braun Medical, Inc.
- Decided: Apr 6, 2011 after 20 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: 7 generations back to K914579 (1992). 30 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072876: Prontosan Wound Irrigation Solution, B.Braun Medical, Inc. (2008) Summary page 1.
- K101882: Prontosan Antimicrobial Wound Gel, B.Braun Medical, Inc. (2010) Summary page 1.

## Most influential descendants
- K141660: Nawalution Skin and Wound Cleanser (2014), 2 descendants of its own
- K252759: revyve® Antimicrobial Skin and Wound Cleanser (2026), 0 descendants of its own
- K250642: LUOFUCON® Skin and Wound Cleanser (Spray, Mist, Squeeze, Bottle.) (2025), 0 descendants of its own
- K231564: Skin and Wound Cleanser (2023), 0 descendants of its own

## Indications for use
Prontosan® Wound Irrigation Solution is intended for cleaning wounds and moistening absorbent wound dressings for the management of minor cuts, abrasions, lacerations and minor bums.

Source page: https://510kreport.com/device/K110744
Methodology: https://510kreport.com/methodology