FIP — Subsystem, Water Purification Class II
FDA Device Classification
Classification Details
- Product Code
- FIP
- Device Class
- Class II
- Regulation Number
- 876.5665
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K250471 | fresenius medical care renal therapies group | AquaC UNO H | November 14, 2025 |
| K251851 | fresenius medical care renal therapies group | DIASAFEplusUS (F00013010) | October 9, 2025 |
| K252181 | fresenius medical care north america | AquaA | September 9, 2025 |
| K250514 | specialty water technologies | UPT Series Medical RO Water Treatment System | March 17, 2025 |
| K232953 | fresenius medical care renal therapies group | AquaBplus; AquaB LITE | June 13, 2024 |
| K223479 | b.braun medical | AQUAbase nX | August 16, 2023 |
| K231410 | evoqua water technologies | RenaPure Endotoxin Retentive Filter | July 19, 2023 |
| K223656 | ameriwater | AmeriWater MediQA Reverse Osmosis System (MSP3HF) | February 13, 2023 |
| K213507 | fresenius medical care rental therapies group | AquaA | July 27, 2022 |
| K211035 | baxter healthcare corporation | U9000 Plus Ultrafilter | October 19, 2021 |
| K200670 | mar cor purification | EON Portable RO Water Purification System | April 16, 2020 |
| K192398 | mar cor purification | Millenium HX | October 3, 2019 |
| K182367 | fresenius medical care renal therapies group | DIASAFEplusUS | January 10, 2019 |
| K171099 | cantel | EON Portable Reverse Osmosis Water Purification System | January 5, 2018 |
| K161304 | nephros | EndoPur Filter | March 2, 2017 |
| K161844 | better water | Matrix Pre-Treatment Controller | December 13, 2016 |
| K153329 | med-tech water systems | MED-TECH Water Systems Inc Exchangeable Carbon Tanks for Dialysis | August 4, 2016 |
| K143617 | vivonic | AquaC UNO H | October 19, 2015 |
| K151637 | specialty water technologies | UPT Series Medical RO Water System | September 23, 2015 |
| K142285 | ameriwater | AmeriWater Heatsan, 3-phase, 208v, 60hz, AmeriWater Heatsan, 3-phase, 460V, 60hz | December 1, 2014 |