# K970253: Cobe Centrysystem 3 Dialysis Control Unit/Cobe Cartridge Blood Tubing Set

- Pathway: 510(k) (Traditional)
- Applicant: Gambro Healthcare
- Decided: Sep 26, 1997 after 247 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
No predicates in its family tree.
10 later devices descend from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K993064: Prisma CFM (Continuous Fluid Management System) (1999), 9 descendants of its own
- K021615: Baxter Accura System, Model 5M5660 (2002), 8 descendants of its own
- K041005: Gambro Prismaflex and Gambro Prismaflex M60 & M100 Sets (2004), 4 descendants of its own
- K080519: Prismaflex M150 Set (2008), 1 descendant of its own
- K070320: Edwards Aquarius Hemofiltration System, Model Abm 01 (2007), 1 descendant of its own

## Indications for use
The Centrysystem® 3 +plus™ Dialysis Control Unit is indicated for patients in acute or chronic renal failure and when hemodialysis is prescribed by the physician. Both high flux and low flux dialyzers may be used with the Centrysystem® 3 +plus™. The modifications to the Centrysystem® 3 do not significantly affect the intended uses previously claimed for this device. This device is a totally self contained machine that provides the necessary control functions for hemodialysis therapy, including: automatically primes the extracorporeal blood circuit (dialyzer and blood tubing set); prepares dialysate; monitors machine subsystems for proper performance and unsafe conditions; pumps blood, dialysate and anticoagulant at predetermined rates; controls fluid removal from the patient; and automatically cleans, disinfects and rinses dialysate flow path. The Centrysystem Cartridge Blood Tubing Set is intended to be used and an extracorporeal circuit accessory to the Centrysystem® 3 +plus™ Dialysis Control Unit described above.

Source page: https://510kreport.com/device/K970253
Methodology: https://510kreport.com/methodology