# K100839: Barirep

- Pathway: 510(k) (Traditional)
- Applicant: Gorbec Pharmaceutical Services, Inc.
- Decided: May 11, 2010 after 48 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 K961758 (1996). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083721: Modification to Zenieva, River'S Edge Pharmaceuticals, LLC (2009) Summary page 2.

## Indications for use
BariRep's intended use Is to manage minor burns, minor abrasions, minor cuts and minor lacerations.

Source page: https://510kreport.com/device/K100839
Methodology: https://510kreport.com/methodology