# K222727: i3 ONE (203100-S);i3 TWO connect (203200-S);i3 TWO direct (203300-S)

- Pathway: 510(k) (Traditional)
- Applicant: I3 Membrane GmbH
- Decided: Jun 2, 2023 after 267 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 intended use of the i3 Membrane Water Filters i3 ONE, i3 TWO connect, i3 TWO direct is to filter EPA quality drinking water. The i3 Membrane Water Filters retain bacteria, which may aid in infection control. The filters produce water that is appropriate for washing and drinking, superficial wound cleansing (minor cuts, scrapes and abrasions), cleaning of equipment used in medical procedures and washing of surgeon's hands. The i3 Membrane Water 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/K222727
Methodology: https://510kreport.com/methodology