FIPClass II
Subsystem, Water Purification
21 CFR 876.5665 / Gastroenterology, Urology
FIP is the FDA product code for Subsystem, Water Purification, a class II device type, regulated under 21 CFR 876.5665. As of , FDA records hold 117 510(k) clearances under this code, the most recent dated , and 15 recalls.
Classification record
- Product code
- FIP
- Device name
- Subsystem, Water Purification
- Regulation
- 21 CFR 876.5665
- Device class
- Class II
- Review panel
- Gastroenterology, Urology
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- Yes
- Ingested clearances
- 117
- Ingested recalls
- 15
Clearances, product code FIP
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1977 | 1 |
| 1979 | 1 |
| 1980 | 2 |
| 1981 | 1 |
| 1982 | 1 |
| 1984 | 2 |
| 1986 | 1 |
| 1987 | 1 |
| 1988 | 1 |
| 1989 | 1 |
| 1990 | 1 |
| 1993 | 1 |
| 1994 | 2 |
| 1995 | 8 |
| 1996 | 3 |
| 1997 | 2 |
| 1998 | 4 |
| 1999 | 3 |
| 2000 | 12 |
| 2001 | 5 |
| 2002 | 5 |
| 2003 | 7 |
| 2004 | 4 |
| 2005 | 5 |
| 2006 | 1 |
| 2007 | 1 |
| 2008 | 3 |
| 2009 | 3 |
| 2010 | 2 |
| 2011 | 4 |
| 2012 | 2 |
| 2013 | 4 |
| 2014 | 4 |
| 2015 | 2 |
| 2016 | 2 |
| 2017 | 1 |
| 2018 | 1 |
| 2019 | 2 |
| 2020 | 1 |
| 2021 | 1 |
| 2022 | 1 |
| 2023 | 3 |
| 2024 | 1 |
| 2025 | 4 |
Applicants with the most clearances
Product code FIP| Applicant | Clearances |
|---|---|
| AmeriWater LLC. | 10 |
| Fresenius Medical Care Renal Therapies Group, LLC | 5 |
| Evoqua Water Technologies LLC | 5 |
| Better Water, Inc. | 4 |
| Dayton Water Systems | 3 |
| Gambro Renal Products | 3 |
| Medivators Inc | 3 |
| Nephros Inc | 3 |
| Usfilter/Ionpure, Inc. | 3 |
| Gambro Healthcare | 2 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.