# K982337: Cuprophan and Hemophan Hollow Fiber Dialyzer

- Pathway: 510(k) (Traditional)
- Applicant: Haidylena Medical Egypt
- Decided: Dec 29, 1998 after 176 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 K864831 (1987). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K864831: Cobe Centrysystem 145E,160E,175E,190E Dialyzers, Cobe Laboratories, Inc. (1987) Summary page 1.
- (no number) Baxter CF25: named in the summary without a submission number
- (no number) Terumo Clirans T175: named in the summary without a submission number

## Most influential descendants
- K991908: Idemsa Hemophan Hollow Fiber Dialyzers (2000), 0 descendants of its own

## Indications for use
The device submitted in this premarket notification are intended for use whenever a patient is in acute or chronic renal failure and hemodialysis is prepared by a physician. Therefore, use of this device should be only on the direction of a physician who has evaluated all of the aspects of the patient’s illness.

Source page: https://510kreport.com/device/K982337
Methodology: https://510kreport.com/methodology