FIP — Subsystem, Water Purification Class II
FDA product code FIP covers "Subsystem, Water Purification", a Class II medical device regulated under 21 CFR 876.5665. Submissions are reviewed by the Gastroenterology, Urology panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |