# K173276: Medline Sterile Water USP and Medline Sterile 0.9% Normal Saline USP

- Pathway: 510(k) (Traditional)
- Applicant: Medline Industries, Inc.
- Decided: Jul 2, 2018 after 263 days
- Product code: FRO (Dressing, Wound, Drug)
- Device class: U
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K945802 (1995). 17 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 19 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083042: Wound Flush, Sterile Water & Normal Saline, Nurse Assist, Inc. (2008) Summary page 4.

## Most influential descendants
- K243001: Sterile Water USP and Sterile 0.9% Normal Saline USP (2025), 0 descendants of its own

## Recalls of this device
- Mar 19, 2025 · Class II · Z-1705-2025: It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking at the interface of the peel-foil and bottle opening.

## Indications for use
For moistening absorbent wound dressings and cleaning minor cuts, minor burns, superficial abrasions and minor irritations of the skin. For moistening absorbent wound dressings and for moistening, debriding and cleaning acute and chronic dermal lesions, such as Stage I-IV pressure ulcers, stasis 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/K173276
Methodology: https://510kreport.com/methodology