# K962427: Cobe Centrysystem 700 HG Hemodialyzer

- Pathway: 510(k) (Traditional)
- Applicant: Gambro Healthcare
- Decided: Sep 20, 1996 after 88 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 K902481 (1990). 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)
- K902481: Gambro Alwall GFS Plus 11, 16 & 20 Hollow Fiber, Gambro, Inc. (1990) Summary page 1.

## Indications for use
The Centrysystem 700 HG can be used whenever hemodialysis is indicated. This dialyzer can be used for long term chronic hemodialysis as well as for acute hemodialysis. In hemodialysis therapy, monitoring of patient vital signs, the dialysate delivery system, heparin administration, and clotting times should be performed under the direction of a physician.

Source page: https://510kreport.com/device/K962427
Methodology: https://510kreport.com/methodology