# K160192: Atteris Antimicrobial Skin & Wound Cleanser

- Pathway: 510(k) (Traditional)
- Applicant: Rochal Industries, LLC
- Decided: Jul 28, 2016 after 183 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). 26 ancestors in all.
9 later devices descend from it; 3 cite it directly.
0 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073547: Anasept Antimicrobial Skin and Wound Cleansers; Anasept Antimicrobial Skin and Wound Gel, Anacapa Technologies, Inc. (2008) Summary page 6.

## Most influential descendants
- K210536: Irrisept Antimicrobial Wound Lavage (2021), 6 descendants of its own
- K213616: BD Surgiphor Antimicrobial Irrigation System (2022), 3 descendants of its own
- K221504: BD Surgiphor™ Antimicrobial Irrigation System (2022), 2 descendants of its own
- K253996: BD Surgiphor™ Antimicrobial Irrigation System (910110) (2026), 0 descendants of its own
- K253445: BD Surgiphor™ 1000 mL Antimicrobial Irrigation System (910120) (2026), 0 descendants of its own

## Indications for use
Rx Only: Atteris Antimicrobial Skin & Wound Cleanser is intended for mechanical cleansing and removal of debris, dirt and foreign materials, including microorganisms from wounds such as stage I-IV pressure ulcers, diabetic foot ulcers, post-surgical wounds, first and second degree burns, grafted and donor sites. OTC use: Atteris Antimicrobial Skin & Wound Cleanser is intended for physical cleaning and removal of dirt and debris, from skin scrapes, cuts, lacerations, minor irritations, exit sites and unbroken skin.

Source page: https://510kreport.com/device/K160192
Methodology: https://510kreport.com/methodology