# K080703: Bti Filtration Deionization Exchange Tank; Bti Filtration Carbon Exchange Tank

- Pathway: 510(k) (Traditional)
- Applicant: 4m Ventures, Inc.
- Decided: Jun 2, 2008 after 82 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: 2 generations back to K894300 (1990). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991519: Ameriwater Purification System for Hemodialysis, Ameriwater (2000) Summary page 1.
- K980182: Water Purification System for Hemodialysis, Usfilter/Ionpure, Inc. (1998) Summary page 1.

## Indications for use
The device is intended to be used as components of a hemodialysis water purification system to remove organic and inorganic substances from water 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. Upon exhaustion, these tanks will be replaced with other Deionization Tanks containing newly regenerated resin or with new resin altogether, or in the case of Carbon Tanks, with tanks containing fresh virgin carbon.

Source page: https://510kreport.com/device/K080703
Methodology: https://510kreport.com/methodology