# K993969: Saljet Single Dose Sterile Saline Topical Solution

- Pathway: 510(k) (Traditional)
- Applicant: Winchester Laboratories, LLC
- Decided: Dec 30, 1999 after 37 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
No predicates in its family tree.
31 later devices descend from it; 2 cite it directly.
1 of 32 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) 20 ml. Normal Saline Topical Solution, 0.9% w/v Sodium Chloride: named in the summary without a submission number

## Most influential descendants
- K040683: Bioderm Sciences Wound Dressing (2004), 29 descendants of its own
- K063063: Silvacide Skin & Wound Moisturizing Solution (2007), 14 descendants of its own
- K083355: Wound Wash Saline, 210 ML, Model B8552, Wound Wash Saline, 90 ML, Model B8553 (2008), 13 descendants of its own
- K042084: Bioderm Sciences Wound Healing Spray (2005), 13 descendants of its own
- K131848: Vashe Wound Solution (4.0 OZ), (8.5 OZ & (16.0 OZ) (2014), 8 descendants of its own

## Indications for use
For use in moistening and lubricating absorbent wound dressings for traumatic wounds, cuts, bruises and minor burns prior to removal from the wound area.

Source page: https://510kreport.com/device/K993969
Methodology: https://510kreport.com/methodology