# K060942: Water Purification Components for Hemodialysis

- Pathway: 510(k) (Traditional)
- Applicant: Bob J. Johnson & Associates
- Decided: Jul 7, 2006 after 92 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K099159: AmeriWater Company Purification System. Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
These Water Purification Devices 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. Note: The Renal Care Facilities will supply their own water treatment system, which consists of water softeners, ultra-filtration, reverse osmosis system, alarms, monitors, tanks, and pumping stations. Bob J. Johnson & Associates will only be providing the activated carbon and deionization components to their systems.

Source page: https://510kreport.com/device/K060942
Methodology: https://510kreport.com/methodology