# K170270: Aqua Care & Accu-Rinse, Sterile Water & Sterile Normal Saline

- Pathway: 510(k) (Traditional)
- Applicant: Ls Scientific Inc. D.B.A. Kse Scientific
- Decided: Jun 23, 2017 after 147 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: 6 generations back to K945802 (1995). 17 ancestors in all.
No later device cites it as a predicate yet.
1 of 18 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.
- K003402: Welcon Sterile Water for Device Irrigation; Welcon Sterile 0.9% Normal Saline for Device Irrigation, Welcon, Inc. (2001) Summary page 4.

## Indications for use
OTC: For moistening absorbent wound dressings and cleaning minor cuts, minor burns, superficial abrasions and minor irritations of the skins. Not for injection. Rx: 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. Not for injection.

Source page: https://510kreport.com/device/K170270
Methodology: https://510kreport.com/methodology