FDA product code FIP: Subsystem, Water Purification
FIP is the FDA product code for subsystem, water purification. It is a Class II device, regulated under 21 CFR 876.5665 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 117 510(k) submissions under FIP, 9 in the last five years, from 85 different applicants. The average 510(k) review took 225 days (median 187); 192 days on average over the last three years. FDA has posted 15 recalls for FIP devices, 6 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Subsystem, Water Purification |
| Device class | Class II |
| Regulation | 21 CFR 876.5665 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for FIP
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 296 |
| 2018 | 1 | 267 |
| 2019 | 2 | 81 |
| 2020 | 1 | 34 |
| 2021 | 1 | 195 |
| 2022 | 1 | 268 |
| 2023 | 3 | 135 |
| 2024 | 1 | 266 |
| 2025 | 4 | 117 |
Compare with all 510(k) review times · Search every FIP clearance
Top FIP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Ameriwater | 9 | 2014-12-01 |
| Fresenius Medical Care Renal Therapies Group, LLC | 4 | 2025-11-14 |
| Mar Cor Purification, Inc. | 4 | 2020-04-16 |
| Nephros, Inc. | 3 | 2017-03-02 |
| Better Water, Inc. | 3 | 2005-11-18 |
80 more applicants have FIP clearances. See the full list in Caduvo.
Most recent FIP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K250471 | Fresenius Medical Care Renal Therapies Group, LLC | AquaC UNO H | 2025-11-14 | 269 |
| K251851 | Fresenius Medical Care Renal Therapies Group, LLC | DIASAFEplusUS (F00013010) | 2025-10-09 | 115 |
| K252181 | Fresenius Medical Care North America | AquaA | 2025-09-09 | 60 |
| K250514 | Specialty Water Technologies, Inc. | UPT Series Medical RO Water Treatment System | 2025-03-17 | 24 |
| K232953 | Fresenius Medical Care Renal Therapies Group, LLC | AquaBplus; AquaB LITE | 2024-06-13 | 266 |
Recalls for FIP devices
15 product recalls in 13 recall events; 6 initiated in the last five years and 6 still open. Most recent: 2024-05-16.
| Year | Recalls |
|---|---|
| 2020 | 1 |
| 2021 | 2 |
| 2022 | 4 |
| 2023 | 1 |
| 2024 | 1 |
Frequently asked questions
What is FDA product code FIP?
FIP is the FDA product code for subsystem, water purification. It is a Class II device, regulated under 21 CFR 876.5665 and reviewed by the Gastroenterology and Urology panel.
What device class is FIP?
Class II, regulation 21 CFR 876.5665. Typical premarket route: 510(k).
How long does a 510(k) take for product code FIP?
Across 117 cleared submissions the average was 225 days from receipt to decision (median 187).
Which companies have the most FIP clearances?
Ameriwater (9); Fresenius Medical Care Renal Therapies Group, LLC (4); Mar Cor Purification, Inc. (4); Nephros, Inc. (3); Better Water, Inc. (3).
Have FIP devices been recalled?
Yes: 15 product recalls across 13 recall events; the most recent began 2024-05-16.
Next steps
- Run an FDA pathway report with predicate devices for product code FIP
- Run a recall and safety report across every FIP manufacturer
- Watch product code FIP for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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