# K982413: Cobe Arylane H1, H4, H6 & H9 Hemodialyzers/Filters

- Pathway: 510(k) (Traditional)
- Applicant: Gambro Healthcare
- Decided: Apr 21, 1999 after 282 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: 1 generation back to K955592 (1997). 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)
- K955592: Cobe Centrysystem 14 Pes Hemodialyzers, Cobe Renal Care, Inc. (1997) Summary page 2.

## Indications for use
The Cobe Arylane Hemodialyzers/Filters H1, H4, H6, H9 are intended for use in hemodialysis and hemofiltration and associated modalities for the treatment of chronic renal failure. The size, weight, state of uremia, cardiac status and general physical condition of the patient must be evaluated by the prescribing physician before each treatment. The choice of the appropriate hemodialyzer/filter and associated equipment as well as the treatment operating parameters are the sole responsibility of the physician.

Source page: https://510kreport.com/device/K982413
Methodology: https://510kreport.com/methodology