# K191563: FILTRAY 2G Disposable Water Filters

- Pathway: 510(k) (Traditional)
- Applicant: Aqua-Tools
- Decided: Oct 25, 2019 after 134 days
- Product code: NHV (System, Water Purification, General Medical Use)
- Device class: 2
- Regulation: 21 CFR 876.5665
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K002045 (2001). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153434: Pall-Aquasafe Water Filter, Pall International Sarl (2016) Summary page 4.
- K153784: Nosogard Filters, Evoqua Water Technologies, LLC (2016) Summary page 4.
- K153084: Nephros S100, Nephros, Inc. (2016) Summary page 4.

## Most influential descendants
- K261470: QF10 (2026), 0 descendants of its own

## Indications for use
The aqua-tools FILT’RAY 2G Disposable Water Filter is intended to be used to filter EPA (Environmental Protection Agency in USA) quality drinking water. By retaining bacteria, the filters may aid in infection control. The filters produce water that is suitable for washing and drinking, superficial wound cleansing (minor cuts, scrapes, or abrasions), cleaning of equipment used in medical procedures and washing of surgeon’s hands. The filters are not intended to provide water that can be used as a substitute for USP grade sterile water.

Source page: https://510kreport.com/device/K191563
Methodology: https://510kreport.com/methodology