# K013550: Clirans E-Series Dialyzer

- Pathway: 510(k) (Special)
- Applicant: Terumo Medical Corp.
- Decided: Nov 20, 2001 after 27 days
- Product code: KDI (Dialyzer, High Permeability With Or Without Sealed Dialysate System)
- Device class: 2
- Regulation: 21 CFR 876.5860
- 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 K926373 (1995). 3 ancestors in all.
1 later device descends from it; 1 cites 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)
- K003425: Clirans E-Series Hollow Fiber Dialyzers, Terumo Medical Corp. (2001) Summary page 1.
- K992573: AF-220 Hemodialyzer, Althin Medical AB (2000) Summary page 3.

## Most influential descendants
- K162248: Asahi ViE-U Series Dialyzer (2017), 0 descendants of its own

## Indications for use
The CLIRANS® E-series Hollow Fiber Dialyzers are indicated for use whenever a patient is found to be in acute or chronic renal failure and hemodialysis is prescribed by a physician. The device should be used only at the direction of a physician who has evaluated all of the pertinent features of the patient’s illness. This device is indicated for single use only.

Source page: https://510kreport.com/device/K013550
Methodology: https://510kreport.com/methodology