# K243001: Sterile Water USP and Sterile 0.9% Normal Saline USP

- Pathway: 510(k) (Traditional)
- Applicant: Laboratorios Biogalenic S.A. DE C.V.
- Decided: Mar 6, 2025 after 161 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: 7 generations back to K945802 (1995). 18 ancestors in all.
No later device cites it as a predicate yet.
1 of 19 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173276: Medline Sterile Water USP and Medline Sterile 0.9% Normal Saline USP, Medline Industries, Inc. (2018) Summary page 5.

## Indications for use
For moistening absorbent wound dressing and cleaning minor cuts, minor burns, superficial abrasions, and minor irritations of the skin. For moistening absorbent wound dressing 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/K243001
Methodology: https://510kreport.com/methodology