# K161212: Atteris Antimicrobial Skin Protectant

- Pathway: 510(k) (Traditional)
- Applicant: Rochal Industries, LLC
- Decided: Sep 30, 2016 after 155 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: 1 generation back to K071371 (2007). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071371: Copa Amd Antimicrobial Wound Dressing, Tyco Healthcare Group LP (2007) Summary page 5.

## Indications for use
Atteris Antimicrobial Barrier Film Dressing is intended for application to minor wounds and damaged skin as a liquid, film forming barrier, which creates a waterproof, film dressing, protecting the wound or damaged skin.

Source page: https://510kreport.com/device/K161212
Methodology: https://510kreport.com/methodology