# K090141: Prontosan Antimicrobial Wound Gel

- Pathway: 510(k) (Traditional)
- Applicant: B.Braun Medical, Inc.
- Decided: Mar 17, 2009 after 55 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.
22 later devices descend from it; 1 cites it directly.
0 of 29 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.

## Most influential descendants
- K101882: Prontosan Antimicrobial Wound Gel (2010), 21 descendants of its own
- K141863: Puricore Wound Hydrogel Spray Dressing (2015), 10 descendants of its own
- K150799: Puracyn (R) Plus Duo-Care (TM) Antimicrobial Wound & Skin Hydrogel,  Puracyn (R) Plus Antimicrobial Hydrogel Professional Formula (2015), 9 descendants of its own
- K110744: Prontosan Wound Irrigation Solution (2011), 4 descendants of its own
- K160095: Simple Science Antimicrobial Wound & Skin Cleanser 2oz, Simple Science Antimicrobial Wound & Skin Cleanser 8oz, Simple Science Antimicrobial Wound & Skin Cleanser 16oz, Simple Science Antimicrobial Wound & Skin Cleanser 23oz (2016), 3 descendants of its own

## Indications for use
Prontosan Tm Wound Gel is intended for moistening and cleansing wounds by maceration of wound coatings and for moistening and lubricating absorbent wound dressings for ulcers, bums, post-surgical wounds, and abrasions.

Source page: https://510kreport.com/device/K090141
Methodology: https://510kreport.com/methodology