# K991908: Idemsa Hemophan Hollow Fiber Dialyzers

- Pathway: 510(k) (Traditional)
- Applicant: Idemsa
- Decided: Apr 17, 2000 after 315 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: 2 generations back to K864831 (1987). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982337: Cuprophan and Hemophan Hollow Fiber Dialyzer, Haidylena Medical Egypt (1998) Summary page 1.
- (no number) Cobe CentrySystem 160E: named in the summary without a submission number
- (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

## Indications for use
The IDEMSA Hemophan Dialyzer has been designed for use in hemodialysis and associated forms of treatment for chronic or acute kidney failure.

Source page: https://510kreport.com/device/K991908
Methodology: https://510kreport.com/methodology