FIP · Subsystem, Water Purification
Gastroenterology, Urology · 21 CFR 876.5665 · Class 2
Overview
| Product Code | FIP |
|---|---|
| Device Name | Subsystem, Water Purification |
| Regulation | 21 CFR 876.5665 |
| Device Class | Class 2 |
| Review Panel | Gastroenterology, Urology |
| 3rd-Party Reviewable | Yes |
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 (20 of 117)
Showing 20 most recent of 117 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K250471 | AquaC UNO H | Fresenius Medical Care Renal Therapies Group, LLC | Nov 14, 2025 | SESE |
| K251851 | DIASAFEplusUS (F00013010) | Fresenius Medical Care Renal Therapies Group, LLC | Oct 9, 2025 | SESE |
| K252181 | AquaA | Fresenius Medical Care North America | Sep 9, 2025 | SESE |
| K250514 | UPT Series Medical RO Water Treatment System | Specialty Water Technologies, Inc. | Mar 17, 2025 | SESE |
| K232953 | AquaBplus; AquaB LITE | Fresenius Medical Care Renal Therapies Group, LLC | Jun 13, 2024 | SESE |
| K223479 | AQUAbase nX | B.Braun Medical, Inc. | Aug 16, 2023 | SESE |
| K231410 | RenaPure Endotoxin Retentive Filter | Evoqua Water Technologies, LLC | Jul 19, 2023 | SESE |
| K223656 | AmeriWater MediQA Reverse Osmosis System (MSP3HF) | AmeriWater, LLC | Feb 13, 2023 | SESE |
| K213507 | AquaA | Fresenius Medical Care Rental Therapies Group, LLC | Jul 27, 2022 | SESE |
| K211035 | U9000 Plus Ultrafilter | Baxter Healthcare Corporation | Oct 19, 2021 | SESE |
| K200670 | EON Portable RO Water Purification System | Mar Cor Purification, Inc. | Apr 16, 2020 | SESE |
| K192398 | Millenium HX | Mar Cor Purification, Inc. | Oct 3, 2019 | SESE |
| K182367 | DIASAFEplusUS | Fresenius Medical Care Renal Therapies Group, LLC | Jan 10, 2019 | SESE |
| K171099 | EON Portable Reverse Osmosis Water Purification System | Cantel | Jan 5, 2018 | SESE |
| K161304 | EndoPur Filter | Nephros, Inc. | Mar 2, 2017 | SESE |
| K161844 | Matrix Pre-Treatment Controller | Better Water, LLC | Dec 13, 2016 | SESE |
| K153329 | MED-TECH Water Systems Inc Exchangeable Carbon Tanks for Dialysis | Med-Tech Water Systems, Inc. | Aug 4, 2016 | SESE |
| K143617 | AquaC UNO H | Vivonic GmbH | Oct 19, 2015 | SESE |
| K151637 | UPT Series Medical RO Water System | Specialty Water Technologies | Sep 23, 2015 | SESE |
| K142285 | AmeriWater Heatsan, 3-phase, 208v, 60hz, AmeriWater Heatsan, 3-phase, 460V, 60hz, Ameriwater Heatsan, 3-phase, 575v, 60hz | Ameriwater | Dec 1, 2014 | SESE |
Top Applicants
- Ameriwater — 9 clearances
- Fresenius Medical Care Renal Therapies Group, LLC — 4 clearances
- Mar Cor Purification, Inc. — 4 clearances
- Better Water, Inc. — 3 clearances
- Dayton Water Systems — 3 clearances
