# K101882: Prontosan Antimicrobial Wound Gel

- Pathway: 510(k) (Traditional)
- Applicant: B.Braun Medical, Inc.
- Decided: Nov 3, 2010 after 120 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 K914579 (1992). 29 ancestors in all.
21 later devices descend from it; 5 cite it directly.
0 of 51 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090141: Prontosan Antimicrobial Wound Gel, B.Braun Medical, Inc. (2009) Summary page 1.
- K073547: Anasept Antimicrobial Skin and Wound Cleansers; Anasept Antimicrobial Skin and Wound Gel, Anacapa Technologies, Inc. (2008) Summary page 1.

## Most influential descendants
- 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
- K181074: Simple Science Antimicrobial Facial and Eyelid Cleanser (2018), 2 descendants of its own

## Indications for use
OTC Use: Prontosan Wound Gel is intended to cleanse and moisten the wound bed and for the management of minor cuts, abrasion, laceration, and minor burns. Professional Use: Prontosan Wound Gel is intend to cleanse and moisten the wound bed and for the management of ulcers, 1st and 2nd degree burns, partial and full thickness wounds, and surgical incisions. It can be used during wound dressing changes to soften encrusted wound dressings.

Source page: https://510kreport.com/device/K101882
Methodology: https://510kreport.com/methodology