# K123910: Woundwash Saline Spray

- Pathway: 510(k) (Traditional)
- Applicant: Neilmed Pharmaceuticals, Inc.
- Decided: Oct 29, 2013 after 314 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). 35 ancestors in all.
No later device cites it as a predicate yet.
0 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083355: Wound Wash Saline, 210 ML, Model B8552, Wound Wash Saline, 90 ML, Model B8553, Blairex Laboratories, Inc. (2008) Summary page 1.

## Indications for use
To cleanse minor wounds and scrapes. The product is not to be used for body cavities, canals, eyes, or mouth.

Source page: https://510kreport.com/device/K123910
Methodology: https://510kreport.com/methodology