# K041163: Isopure Complete Water System for Hemodialysis, MD 400 and MD 600 Series

- Pathway: 510(k) (Traditional)
- Applicant: Isopure, Corp.
- Decided: Oct 7, 2004 after 157 days
- Product code: FIP (Subsystem, Water Purification)
- Device class: 2
- Regulation: 21 CFR 876.5665
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 4 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K051620: Matrix Digital Reverse Osmosis Water Treatment System, Model Eqrmd Series (2005), 3 descendants of its own
- K151637: UPT Series Medical RO Water System (2015), 1 descendant of its own
- K250514: UPT Series Medical RO Water Treatment System (2025), 0 descendants of its own
- K161844: Matrix Pre-Treatment Controller (2016), 0 descendants of its own

## Recalls of this device
- Oct 24, 2011 · Not classified · Z-0190-2012: The cleaning solution Step 2, 3000-22000 GPD labeled bottles (NaOH) were filled with Step 1, 3000-22000 GPD chemical (HCl).

## Indications for use
The Isopure Complete Water Purification System each device is intended for use in Hemodialysis systems and is intended to remove organic and inorganic substances and microbial contaminants from water used to dilute dialysate concentrate to form dialysate. These systems are to be use in Hospitals and/or Hemodialysis facilities. Each indirect feed model has the following optional configuration: MD61 0 - Single distribution pump with a series of ultra-filters based on the required flow of the facility. The MD610 has no Deionization capabilities. MD620 - Dual multi-stage distribution pumps with a series of ultra-filters based on the required flow of the facility. The MD620 has no Deionization capabilities. MD630 - Single multi-stage distribution pump with a series of ultra-filters based on the required flow of the facility. The MD630 is equipped to process a single bank of medical grade Deionization exchange tanks. MD640 - Dual multistage distribution pumps with automatic pump alternation with a series of ultra-filters based on the required flow of the facility. The MD640 is equipped to process dual banks of medical grade Deionization exchange tanks. The MD640 is capable of operating continuously by automatically alternating between the two banks of exchange tanks.

Source page: https://510kreport.com/device/K041163
Methodology: https://510kreport.com/methodology