# K993520: H20NLY Complete Water Purification System for Hemodialysis

- Pathway: 510(k) (Traditional)
- Applicant: Serv-A-Pure Co.
- Decided: May 3, 2000 after 198 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 K931595 (1994). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980182: Water Purification System for Hemodialysis, Usfilter/Ionpure, Inc. (1998) Summary page 1.
- K931595: Reverse Osmosis Equipment for Water Purification, Osmonics, Inc. (1994) Summary page 1.
- K920186: Water Purification System for Hemodialysis, Better Water, Inc. (1995) Summary page 1.

## Indications for use
H20nly Water Purification 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/K993520
Methodology: https://510kreport.com/methodology