# FIN: Tank, Holding, Dialysis

- Device class: 2; regulation: 21 CFR 876.5820; FDA's rule: 510(k) required
- FDA decisions: 18
- Recalls: 2 (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)
- 1999: 1
- 2000: 2
- 2001: 1
- 2003: 1
- 2004: 3
- 2006: 2
- 2010: 1
- 2012: 1
- 2014: 1
- 2015: 1

## Most-cited predicates
- K970674: G.E.M. Water Systems, International (1997), cited by 3
- K093641: TANGO3 Water Storage Tank with Ozone Disinfection System (2010), cited by 3
- K003560: Mar Cor Services Bicarb System (2001), cited by 2
- K993058: Pure Water Inc's Acidified Storage and Distribution System with Optional Remote Fill (2000), cited by 1
- K993272: Pure Water, Inc.'S Bicarb Mix, Storage and Distribution System (2000), cited by 1
- K031502: Usfilter Bicarbonate Mixing and Dispensing (Bicarb) System (2004), cited by 1
- K992793: Sodium Bicarbonate Mixing/Delivery System, and the Concentrate Delivery System (1999), cited by 1

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