# K163609: Pall QPoint Water Filter Capsule (Shower), Pall QPoint Water Filter Capsule (Faucet)

- Pathway: 510(k) (Traditional)
- Applicant: Pall International Sarl
- Decided: Jun 1, 2017 after 161 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). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 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.

## Indications for use
The Pall® QPoint™ Water Filter Capsule is intended to be used within the healthcare environment such as hospitals, nursing homes, healthcare facilities or clinical setting where immune-compromised patients may be exposed to waterborne microorganisms originating from the water supply. The Pall® QPoint™ Water Filter Capsule is intended to be used to filter EPA (Environmental Protection Agency in USA) quality drinking water. By retaining bacteria, fungi and protozoa 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 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/K163609
Methodology: https://510kreport.com/methodology