# K970708: Clirans T-Series Hollow Fiber Dialyzers

- Pathway: 510(k) (Traditional)
- Applicant: Terumo Medical Corp.
- Decided: Dec 19, 1997 after 296 days
- Product code: FJI (Dialyzer, Capillary, Hollow Fiber)
- Device class: 2
- Regulation: 21 CFR 876.5820
- 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 K854280 (1985). 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)
- K854280: Clirans Taf Hollow Fiber Dialyzer, Terumo Medical Corp. (1985) Summary page 1.

## Indications for use
The CLIRANS® T-Series Hollow Fiber Dialyzers are devices used as part of an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and that consists of an extracorporeal blood system, a conventional dialyzer, a dialysate delivery system, and accessories. This device is indicated for single and multiple use.

Source page: https://510kreport.com/device/K970708
Methodology: https://510kreport.com/methodology