# K181423: AMSure Sterile Water, and Sterile Normal Saline for Wound Flush

- Pathway: 510(k) (Traditional)
- Applicant: Amsino International, Inc.
- Decided: Sep 7, 2018 after 99 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: 8 generations back to K945802 (1995). 19 ancestors in all.
No later device cites it as a predicate yet.
1 of 20 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172486: Anexa Wound Flush, USP Sterile Water, and USP Sterile Normal Saline (0.9% sodium chloride) 120 mL cup, USP Sterile Water, and USP Sterile Normal Saline (0.9% sodium chloride) 100mL bottle, USP Sterile Water, and USP Sterile Normal Saline (0.9% sodium chloride) 250mL bottle, USP Sterile Water, and USP Sterile Normal Saline (0.9% sodium chloride) 500mL bottle, Anexa Biomedical, Inc. (2017) Summary page 4.
- K083042: Wound Flush, Sterile Water & Normal Saline, Nurse Assist, Inc. (2008) Summary page 4.

## Indications for use
AMSure® Sterile Water, and Sterile Normal Saline for Wound Flush - For over-the-counter use: For moistening absorbent wound dressing and cleaning minor cuts, minor burns, superficial abrasions and minor irritations of the skin. - For prescription use: For moistening absorbent wound dressing and for moistening, debriding and cleaning acute and chronic dermal lesions, such as Stage I-IV pressure ulcers, diabetic ulcers, foot ulcers, post-surgical wounds, first and second degree burns, cuts, abrasions and minor skin irritations and for device irrigation.

Source page: https://510kreport.com/device/K181423
Methodology: https://510kreport.com/methodology