510(k) · Cleared
Clearedi3 ONE (203100-S);i3 TWO connect (203200-S);i3 TWO direct (203300-S)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
I3 Membrane GmbH · NHV System, Water Purification, General Medical Use
Cleared on Jun 2, 2023 as substantially equivalent to K153434 (Pall International Sarl, 2016) after a 267-day review. Its family tree reaches back 4 generations to 2001.
- Decided
- Jun 2, 2023
- Review
- 267 days
- Class
- Class II
- Product code
- NHV
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K002045 (2001). No later device cites it as a predicate yet.
- Root · 4 generations backK002045 Water Purification System for HemodialysisTotal Water Treatment Systems, Inc. · 2001
- 3 generations backK012716 Mainstream Water Purification DevicePrismedical Corp. · 2002
- 2 generations backK141731 Nephros Dsu-H, Nephros Ssu-HNephros, Inc. · 2014
- 1 generation backK153434 Pall-Aquasafe Water FilterPall International Sarl · 2016
- This deviceK222727 i3 ONE (203100-S);i3 TWO connect (203200-S);i3 TWO direct (203300-S)I3 Membrane GmbH · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K002045 | Water Purification System for Hemodialysis | Total Water Treatment Systems, Inc. | 2001 | — |
| −3 | K012716 | Mainstream Water Purification Device | Prismedical Corp. | 2002 | — |
| −2 | K141731 | Nephros Dsu-H, Nephros Ssu-H | Nephros, Inc. | 2014 | — |
| −1 | K153434 | Pall-Aquasafe Water Filter | Pall International Sarl | 2016 | — |
| 0 (this device) | K222727 | i3 ONE (203100-S);i3 TWO connect (203200-S);i3 TWO direct (203300-S) | I3 Membrane GmbH | 2023 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NHV? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new NHV device
- #1 K261470 QF10score 13.2 · 5 generations · no Class I recall
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K153434 | Pall-Aquasafe Water FilterSummary page 4…hemodialysis Classification Product Code: NHV Panel: Gastroenterology/Urology Predicate Device: Pall-Aquasafe Water Filter, K153434 Reference Device: Ecolab POU Water Filter, K182164… | 2016 |
| † | K182164 | Ecolab POU Water Filter Spray Outlet, Ecolab POU Water Filter Nozzle Outlet, Ecolab POU… | 2019 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 5 companies; a new generation was cleared every 7.0 years on median.
- None of the 4 ancestors has a recall.
- 2 other devices also cite its predicate K153434.
How does its category compare?
All NHV devicesNHV System, Water Purification, General Medical Use: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · NHV
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · NHV
203in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NHV
No recall names NHV since 2007.
Adverse event reports per year · NHV
1in 2025
MAUDE reports naming product code NHV, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 4 | 203 | 0 | 0 |
| 2017 | 1 | — | 0 | 1 |
| 2018 | 1 | — | 0 | 2 |
| 2019 | 2 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 4 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222727 · printed Nov 5, 2026
Cite this page
510(k) Report. “K222727: i3 ONE (203100-S);i3 TWO connect (203200-S);i3 TWO direct (203300-S).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K222727
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026