# K014169: Water Purification Components for Hemodialysis

- Pathway: 510(k) (Traditional)
- Applicant: Bob J. Johnson & Assoc., Inc.
- Decided: Feb 6, 2002 after 49 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 K980182 (1998). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 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.

## Indications for use
Carbon Filters and Water Softeners are intended to be used as components of a water purification system to remove organic and inorganic substances from water that is used to dilute dialysis concentrate to form dialysate and to produce purified water for other purposes such as dialyzer reprocessing and equipment rinse and disinfection

Source page: https://510kreport.com/device/K014169
Methodology: https://510kreport.com/methodology