System, Water Purification, General Medical Use
FDA product code NHV · Class II (moderate risk) · 21 CFR 876.5665 · Gastroenterology, Urology
The device is a portable water treatment system which features components and technology similar to water treatment systems previously cleared for hemodialysis. The difference lies with the intended use, as the proposed device is not intended for use in hemodialysis applications, for which a product code currently exists. Instead, the proposed device is intended for use to purify water for general purposes, including washing of surgeons hands, surgical instruments, and wound cleansing.
12510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261470 | PurGuard360(QF10)NHV · Traditional | E.A.M Benelux B.V | 09/09/2026SE |
| K222727 | i3 ONE (203100-S);i3 TWO connect (203200-S);i3 TWO direct (203300-S)NHV · Traditional | I3 Membrane GmbH | 06/02/2023SE |
| K191563 | FILTRAY 2G Disposable Water FiltersNHV · Traditional | Aqua-Tools | 10/25/2019SE |
| K182164 | Ecolab POU Water Filter Spray Outlet, Ecolab POU Water Filter Nozzle Outlet, Ecolab POU…NHV · Special | Ecolab, Inc. | 03/29/2019SE |
| K173164 | Ecolab POU Water FilterNHV · Traditional | Ecolab, Inc. | 06/29/2018SE |
| K163609 | Pall QPoint Water Filter Capsule (Shower), Pall QPoint Water Filter Capsule (Faucet)NHV · Traditional | Pall International Sarl | 06/01/2017SE |
| K161467 | HydraGuard 10 UltraFilterNHV · Special | Nephros, Inc. | 12/22/2016SE |
| K153784 | Nosogard FiltersNHV · Traditional | Evoqua Water Technologies, LLC | 10/21/2016SE |
| K153434 | Pall-Aquasafe Water FilterNHV · Traditional | Pall International Sarl | 06/10/2016SE |
| K153084 | Nephros S100NHV · Traditional | Nephros, Inc. | 04/08/2016SE |
| K141731 | Nephros Dsu-H, Nephros Ssu-HNHV · Traditional | Nephros, Inc. | 10/24/2014SE |
| K012716 | Mainstream Water Purification DeviceNHV · Traditional | Prismedical Corp. | 05/07/2002SE |