# K981680: Ultrapure Water Treatment System for Hemodialysis

- Pathway: 510(k) (Traditional)
- Applicant: Dayton Water Systems
- Decided: Dec 31, 1998 after 232 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
Longest line of descent: 1 generation back to K920186 (1995). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K920186: Water Purification System for Hemodialysis, Better Water, Inc. (1995) Summary page 1.

## Most influential descendants
- K991916: Virginia Water Systems' Water Purification System for Hemodialysis (2000), 0 descendants of its own

## Indications for use
Dayton Water Systems’ UltraPure Water Treatment System for Hemodialysis is intended for use in hemodialysis treatment. It is intended to remove organic and inorganic substances and microbial contaminants from water used to dilute dialysate concentrate to form dialysate. When used as a medical device, Federal law restricts this device to sale by or on the order of a physician.

Source page: https://510kreport.com/device/K981680
Methodology: https://510kreport.com/methodology