# K002045: Water Purification System for Hemodialysis

- Pathway: 510(k) (Traditional)
- Applicant: Total Water Treatment Systems, Inc.
- Decided: Feb 16, 2001 after 226 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.
12 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K012716: Mainstream Water Purification Device (2002), 10 descendants of its own
- K141731: Nephros Dsu-H, Nephros Ssu-H (2014), 9 descendants of its own
- K153784: Nosogard Filters (2016), 4 descendants of its own
- K153434: Pall-Aquasafe Water Filter (2016), 4 descendants of its own
- K153084: Nephros S100 (2016), 2 descendants of its own

Source page: https://510kreport.com/device/K002045
Methodology: https://510kreport.com/methodology