Product code FIP
- Device name
- Subsystem, Water Purification
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation number
- 876.5665
- Review panel
- GU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Ineligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K250471 | AquaC UNO H | Fresenius Medical Care Renal Therapies Group, LLC | 2025-11-14 |
| K251851 | DIASAFEplusUS (F00013010) | Fresenius Medical Care Renal Therapies Group, LLC | 2025-10-09 |
| K252181 | AquaA | Fresenius Medical Care North America | 2025-09-09 |
| K250514 | UPT Series Medical RO Water Treatment System | Specialty Water Technologies, Inc. | 2025-03-17 |
| K232953 | AquaBplus; AquaB LITE | Fresenius Medical Care Renal Therapies Group, LLC | 2024-06-13 |
| K223479 | AQUAbase nX | B.Braun Medical, Inc. | 2023-08-16 |
| K231410 | RenaPure Endotoxin Retentive Filter | Evoqua Water Technologies, LLC | 2023-07-19 |
| K223656 | AmeriWater MediQA Reverse Osmosis System (MSP3HF) | AmeriWater, LLC | 2023-02-13 |
| K213507 | AquaA | Fresenius Medical Care Rental Therapies Group, LLC | 2022-07-27 |
| K211035 | U9000 Plus Ultrafilter | Baxter Healthcare Corporation | 2021-10-19 |
| K200670 | EON Portable RO Water Purification System | Mar Cor Purification, Inc. | 2020-04-16 |
| K192398 | Millenium HX | Mar Cor Purification, Inc. | 2019-10-03 |
| K182367 | DIASAFEplusUS | Fresenius Medical Care Renal Therapies Group, LLC | 2019-01-10 |
| K171099 | EON Portable Reverse Osmosis Water Purification System | Cantel | 2018-01-05 |
| K161304 | EndoPur Filter | Nephros, Inc. | 2017-03-02 |
| K161844 | Matrix Pre-Treatment Controller | Better Water, LLC | 2016-12-13 |
| K153329 | MED-TECH Water Systems Inc Exchangeable Carbon Tanks for Dialysis | Med-Tech Water Systems, Inc. | 2016-08-04 |
| K143617 | AquaC UNO H | Vivonic GmbH | 2015-10-19 |
| K151637 | UPT Series Medical RO Water System | Specialty Water Technologies | 2015-09-23 |
| K142285 | AmeriWater Heatsan, 3-phase, 208v, 60hz, AmeriWater Heatsan, 3-phase, 460V, 60hz, Ameriwater Heatsan, 3-phase, 575v, 60hz | Ameriwater | 2014-12-01 |
| K133149 | BIOPURE HX2 REVERSE OSMOSIS WATER PURIFICATION SYSTEM | Mar Cor Purification, Inc. | 2014-04-30 |
| K133829 | AQUABPLUS,AQUABPLUS & AQUABPLUS B2,AQUABPLUS&AQUABPLUS HF,AQUABPLUS& AQUABPLUS B2& AQUABLUS HF | Vivonic GmbH | 2014-04-22 |
| K133783 | AMERIWATER CENTURION 1500+ REVERSE OSMOSIS SYSTEM WITH HEAT SANITIZATION | Ameriwater | 2014-04-16 |
| K131904 | MEDIQA SINGLE PASS REVERSE OSMOSIS SYSTEM WITH HEAT SANITIZATION, MEDIQA DOUBLE PASS REVERSE OSMOSIS SYSTEM WITH HEAT SA | Ameriwater | 2013-11-13 |
| K131622 | MROZ REVERSE OSMOSIS SYSTEM | Ameriwater | 2013-09-20 |
| K123282 | DEONIZATION EXCHANGE TANKS, CARBON EXCHANGE TANKS | Ultrapure & Industrial Services, LLC | 2013-04-25 |
| K124059 | AQUABOSS ECORO DIA I (HT); AQUABOSS ECORO DIA II (HT) | Lauer Membran Wassertechnik GmbH | 2013-03-25 |
| K121022 | AMERIWATER ALARM PANEL - BASE MODEL AND REMOTE, BASE MODEL & REMOTE WITH CONDUCTIVITY, BASE MODEL & REMOTE WITH RESISTIV | Ameriwater | 2012-09-17 |
| K112331 | BIOPURE PORTABLE RO SYSTEMS | Arion Water, Inc. | 2012-07-05 |
| K111740 | AMERIWATER MRO PORTABLE REVERSE OSMOSIS SYSTEM - SINGLE PATIENT, 1 TO 3 STATION | Ameriwater | 2011-10-05 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| B297APT57250 | Hurricane Filter Assembly w/ Reject Assembly - Digital | SPECIALITY WATER TECHNOLOGY | 2019-07-22 |
| B297KAMT2A14306BT20 | Organic Scavenger | SPECIALITY WATER TECHNOLOGY | 2019-07-22 |
| PS0105 | POSTTREAT, 4UF, 230V, DTD | BETTER WATER, LLC | 2019-06-28 |
| RO0105 | 2020RO, 5400GPD, 208V, 3MEM | BETTER WATER, LLC | 2016-10-13 |
| RO0104 | 2020RO, 5400GPD, 230V, 3MEM | BETTER WATER, LLC | 2016-10-13 |
| RO0103 | 2020RO, 3600GPD, 208V, 2MEM | BETTER WATER, LLC | 2016-10-13 |
| RO0102 | 2020RO, 3600GPD, 460V, 2MEM | BETTER WATER, LLC | 2016-10-13 |
| RO0101 | 2020RO, 3600GPD, 230V, 2MEM | BETTER WATER, LLC | 2016-10-13 |
| RO0001 | 1232RO, 2880GPD, 120V, 4MEM | BETTER WATER, LLC | 2016-10-13 |
| PS0154 | "POSTTREAT, .03 30"", 208V, DTD" | BETTER WATER, LLC | 2016-10-13 |
| PS0153 | "POSTTREAT, .03 30"", 230V, DTD" | BETTER WATER, LLC | 2016-10-13 |
| PS0152 | "POSTTREAT, .03 30"", 208V, DTD" | BETTER WATER, LLC | 2016-10-13 |
| PS0151 | "POSTTREAT, .03 30"", 208V" | BETTER WATER, LLC | 2016-10-13 |
| PS0104 | POSTTREAT, 4UF, 208V, DTD | BETTER WATER, LLC | 2016-10-13 |
| PS0103 | POSTTREAT, 3UF, 208V, DTD | BETTER WATER, LLC | 2016-10-13 |
| PS0102 | POSTTREAT, 3UF, 208V | BETTER WATER, LLC | 2016-10-13 |
| PS0101 | POSTTREAT, 2UF, 208V, DTD | BETTER WATER, LLC | 2016-10-13 |
| PS0003 | POSTTREAT RACK, 4UF, 208V, 2 PUMPS | BETTER WATER, LLC | 2016-10-13 |
| PS0002 | POSTTREAT RACK, 4UF, 208V, 1 PUMP | BETTER WATER, LLC | 2016-10-13 |
| PS0001 | "POSTTREAT RACK, .03 30"", 208V, 2 PUMPS" | BETTER WATER, LLC | 2016-10-13 |
| PR0005 | "PRETREAT, 1.5"", 208V, 2PUMPS, CPVC" | BETTER WATER, LLC | 2016-10-13 |
| PR0004 | "PRETREAT, 1.5"", 208V, CPVC" | BETTER WATER, LLC | 2016-10-13 |
| PR0003 | "PRETREAT, 1.5"", 230V CPVC" | BETTER WATER, LLC | 2016-10-13 |
| PR0002 | "PRETREAT, 1"", 208V, CPVC" | BETTER WATER, LLC | 2016-10-13 |
| PR0001 | "PRETREAT, 1"", 230V, CPVC" | BETTER WATER, LLC | 2016-10-13 |
| PB0001 | UL LISTED MEDI-PORT PBII R.O. 120V | BETTER WATER, LLC | 2016-10-13 |
| MP0002 | MEDIPAC, 2880GPD, TANK FEED, 115V | BETTER WATER, LLC | 2016-10-13 |
| MP0001 | MEDIPAC, 2880GPD, DIRECT FEED, 115V | BETTER WATER, LLC | 2016-10-13 |
| M17451091 | Serim® GUARDIAN™ HiSENSE™ Test Kit | SERIM RESEARCH CORPORATION | 2016-09-19 |
| M985085003210 | MesaLabs | MESA LABORATORIES, INC. | 2015-10-28 |