# K201138: AMSure® Single Use Saline Topical Solution

- Pathway: 510(k) (Traditional)
- Applicant: Amsino Medical, Inc.
- Decided: Apr 14, 2021 after 351 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 K993969 (1999). 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)
- K993969: Saljet Single Dose Sterile Saline Topical Solution, Winchester Laboratories, LLC (1999) Summary page 4.

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

Source page: https://510kreport.com/device/K201138
Methodology: https://510kreport.com/methodology