# K131176: Ross RU Skin Discontinuities

- Pathway: 510(k) (Traditional)
- Applicant: Biotd S.A.
- Decided: May 12, 2014 after 382 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 K914579 (1992). 18 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082333: Asap Wound Dressing Gel, American Biotech Labs (2009) Summary page 1.

## Most influential descendants
- K150985: Medihoney Wound Gel (2015), 0 descendants of its own

## Indications for use
An over-the-counter (OTC) product for topical management of minor cuts, lacerations, abrasions, 1st and 2nd degree burns, and skin irritations.

Source page: https://510kreport.com/device/K131176
Methodology: https://510kreport.com/methodology