# K991916: Virginia Water Systems' Water Purification System for Hemodialysis

- Pathway: 510(k) (Traditional)
- Applicant: Virginia Water Systems, Inc.
- Decided: Jan 14, 2000 after 221 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: 2 generations back to K873487 (1987). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K931595: Reverse Osmosis Equipment for Water Purification, Osmonics, Inc. (1994) Summary page 1.
- K945559: Mar Cor Complete Water Treatment System for Kdney Dialysis, Mar Cor Services, Inc. (1996) Summary page 1.
- K974899: Gambro Central Water Treatment System CWP 100 - Wro H, Gambro Healthcare (1998) Summary page 1.
- K981680: Ultrapure Water Treatment System for Hemodialysis, Dayton Water Systems (1998) Summary page 1.

## Indications for use
Virginia Water Systems' Water Purification for Hemodialysis is intended to remove organic, inorganic, and microbial contaminants from water used to make dialysate and reprocess dialyzers as well as rinsing and disinfection of the dialysis equipment. 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/K991916
Methodology: https://510kreport.com/methodology