NHV · System, Water Purification, General Medical Use
Gastroenterology, Urology · 21 CFR 876.5665 · Class 2
Overview
| Product Code | NHV |
|---|---|
| Device Name | System, Water Purification, General Medical Use |
| Regulation | 21 CFR 876.5665 |
| Device Class | Class 2 |
| Review Panel | Gastroenterology, Urology |
Identification
A water purification system for hemodialysis is a device that is intended for use with a hemodialysis system and that is intended to remove organic and inorganic substances and microbial contaminants from water used to dilute dialysate concentrate to form dialysate. This generic type of device may include a water softener, sediment filter, carbon filter, and water distillation system.
Classification Rationale
Class II (special controls). The device, when it is a water purification subsystem disinfectant, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
Special Controls
*Classification.* Class II (special controls). The device, when it is a water purification subsystem disinfectant, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
Recent Cleared Devices (11 of 11)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K222727 | i3 ONE (203100-S);i3 TWO connect (203200-S);i3 TWO direct (203300-S) | I3 Membrane GmbH | Jun 2, 2023 | SESE |
| K191563 | FILTRAY 2G Disposable Water Filters | Aqua-Tools | Oct 25, 2019 | SESE |
| K182164 | Ecolab POU Water Filter Spray Outlet, Ecolab POU Water Filter Nozzle Outlet, Ecolab POU Water Filter Shower Wand | Ecolab, Inc. | Mar 29, 2019 | SESE |
| K173164 | Ecolab POU Water Filter | Ecolab, Inc. | Jun 29, 2018 | SESE |
| K163609 | Pall QPoint Water Filter Capsule (Shower), Pall QPoint Water Filter Capsule (Faucet) | Pall International Sarl | Jun 1, 2017 | SESE |
| K161467 | HydraGuard 10 UltraFilter | Nephros, Inc. | Dec 22, 2016 | SESE |
| K153784 | NOSOGARD FILTERS | Evoqua Water Technologies, LLC | Oct 21, 2016 | SESE |
| K153434 | Pall-Aquasafe Water Filter | Pall International Sarl | Jun 10, 2016 | SESE |
| K153084 | Nephros S100 | Nephros, Inc. | Apr 8, 2016 | SESE |
| K141731 | NEPHROS DSU-H, NEPHROS SSU-H | Nephros, Inc. | Oct 24, 2014 | SESE |
| K012716 | MAINSTREAM WATER PURIFICATION DEVICE | Prismedical Corp. | May 7, 2002 | SESE |
Top Applicants
- Nephros, Inc. — 3 clearances
- Ecolab, Inc. — 2 clearances
- Pall International Sarl — 2 clearances
- Aqua-Tools — 1 clearance
- Evoqua Water Technologies, LLC — 1 clearance
