# K261470: QF10

- Pathway: 510(k) (Traditional)
- Applicant: E.A.M Benelux B.V
- Decided: Sep 9, 2026 after 128 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: 5 generations back to K002045 (2001). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191563: FILTRAY 2G Disposable Water Filters, Aqua-Tools (2019) Summary page 5.

## Indications for use
The QF10 is intended to be used to filter EPA-quality drinking water. By retaining bacteria, the filter 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 filter is not intended to provide water that can be used as a substitute for USP-grade sterile water.

Source page: https://510kreport.com/device/K261470
Methodology: https://510kreport.com/methodology