# K161623: Prontosan Wound Irrigation Solution, 40 mL, Prontosan Wound Irrigation Solution, 350 mL, Prontosan Wound Irrigation Solution, 1000 mL

- Pathway: 510(k) (Traditional)
- Applicant: B.Braun Medical, Inc.
- Decided: Nov 10, 2016 after 150 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 K945802 (1995). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 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 4.

## Most influential descendants
- K250642: LUOFUCON® Skin and Wound Cleanser (Spray, Mist, Squeeze, Bottle.) (2025), 0 descendants of its own

## Indications for use
Prontosan Wound Irrigation Solution is intended for cleaning wounds and for moistening and lubricating absorbent wound dressings for ulcers, burns, post-surgical wounds and abrasions.

Source page: https://510kreport.com/device/K161623
Methodology: https://510kreport.com/methodology