# K980182: Water Purification System for Hemodialysis

- Pathway: 510(k) (Traditional)
- Applicant: Usfilter/Ionpure, Inc.
- Decided: Nov 16, 1998 after 300 days
- Product code: FIP (Subsystem, Water Purification)
- Device class: 2
- Regulation: 21 CFR 876.5665
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
9 later devices descend from it; 7 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K030348: Biopure Portable RO System,Biopure 4400 Series RO System, Biopure 8400 Series RO System,Biopure Water Purfication Pretre (2003), 2 descendants of its own
- K133149: Biopure HX2 Reverse Osmosis Water Purification System (2014), 0 descendants of its own
- K112331: Biopure Portable RO Systems (2012), 0 descendants of its own
- K080703: Bti Filtration Deionization Exchange Tank; Bti Filtration Carbon Exchange Tank (2008), 0 descendants of its own
- K071104: Acute Portable Exchange Deionization (Pedi) System, Central Pedi System, Back-UP Pedi System (2008), 0 descendants of its own

## Indications for use
The USFilter water purification systems discussed in this premarket notification are intended for use in hemodialysis applications. The water purification systems are used to remove organic and inorganic substances and microbial contaminants from water used to dilute dialysis concentrate and to produce dialysis water and purified water for purposes such as dialyzer reprocessing and final rinse and disinfection.

Source page: https://510kreport.com/device/K980182
Methodology: https://510kreport.com/methodology