# K991495: Fluid Process Systems Exchange Carbon and Deionization Tanks for Use in Hemodialysis

- Pathway: 510(k) (Traditional)
- Applicant: Fluid Process Systems, Inc.
- Decided: Aug 28, 2000 after 488 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 FDA summary names no predicate by number.

## Indications for use
The intended use of this system, comprising of the following components, is to provide water to dilute dialysate for use in HEMODIALYSIS applications., Carbon Tank (see description inside the application) Cation Deionization Tank Anion Deionization Tank Mixed Bed Deionization Tank Mixed Bed Deionization Tank (used as a polisher tank) The combination of the above listed components will deliver water which exceeds AAMI Standards for water used to dilute dialysate for HEMODIALYSIS. The system does not come into contact with any patient and is used solely as indicated. The components are used in this serles (without exception) and are ‘ not designed to be bypassed at any paint. The process requires additional components which are added qr fumished by the end user. These include an LTRAVIOLET DISINFECTION-SSlls al‘and an ULTRAFILTER, with a rating of -05 micron, to reduced the risk of pyrogens being passed through the system. The instruction manual outlines several tests which are required prior to use prior to every patient shift. The final decision to use the water for HEMODIALYSIS rests with the medical director.

Source page: https://510kreport.com/device/K991495
Methodology: https://510kreport.com/methodology