FIP
- Product code
- FIP
- Device name
- Subsystem, Water Purification
- Device class
- Class 2
- 21 CFR
- 21 CFR 876.5665
- Medical specialty
- Gastroenterology, Urology
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 5
- Summaries archived here
- 5 (direct download)
- 510(k) clearances (all years, FDA)
- 117 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (5)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K250471 | 2025-11-14 | Fresenius Medical Care Renal Therapies… | AquaC UNO H | |
| K251851 | 2025-10-09 | Fresenius Medical Care Renal Therapies… | DIASAFEplusUS (F00013010) | |
| K252181 | 2025-09-09 | Fresenius Medical Care North America | AquaA | |
| K250514 | 2025-03-17 | Specialty Water Technologies, Inc. | UPT Series Medical RO Water Treatment System | |
| K232953 | 2024-06-13 | Fresenius Medical Care Renal Therapies… | AquaBplus; AquaB LITE |
Official FDA classification page: FIP
Classification and pathway per current FDA publications. Data from openFDA (CC0).