# FIP: Subsystem, Water Purification

- Device class: 2; regulation: 21 CFR 876.5665; FDA's rule: 510(k) required
- FDA decisions: 117
- 510(k) review time 2021–2025: median 155 days (middle half 66–268)
- Recalls: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2016: 2
- 2017: 1
- 2018: 1
- 2019: 2
- 2020: 1
- 2021: 1
- 2022: 1
- 2023: 3
- 2024: 1
- 2025: 4

## Most-cited predicates
- K991519: Ameriwater Purification System for Hemodialysis (2000), cited by 10
- K920186: Water Purification System for Hemodialysis (1995), cited by 9
- K964539: Portable Series Reverse Osmosis Systems 700, 701, 702, 703, 704, 750, Mre-NF, F800-F802, RO Secura, Reverse Osmosis Syst (1997), cited by 8
- K980182: Water Purification System for Hemodialysis (1998), cited by 7
- K093608: Gambro Water Purification Unit, Models Wro 300 and Wro 300 H (2010), cited by 5
- K974899: Gambro Central Water Treatment System CWP 100 - Wro H (1998), cited by 5
- K110578: Millenium HX Portable Reverse Osmosis Water Purification System (2011), cited by 4
- K945559: Mar Cor Complete Water Treatment System for Kdney Dialysis (1996), cited by 4
- K041163: Isopure Complete Water System for Hemodialysis, MD 400 and MD 600 Series (2004), cited by 4
- K924695: Aseptech Portable RO+ System (1995), cited by 3

Source page: https://510kreport.com/product-code/FIP
Data by year (CSV): https://510kreport.com/product-code/FIP.csv