# K955592: Cobe Centrysystem 14 Pes Hemodialyzers

- Pathway: 510(k) (Traditional)
- Applicant: Cobe Renal Care, Inc.
- Decided: Apr 30, 1997 after 510 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.
38 later devices descend from it; 2 cite it directly.
0 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Fresenius F80 A Hemodialyzer: named in the summary without a submission number
- (no number) Gambro HC 14R Hemoconcentrator: named in the summary without a submission number

## Most influential descendants
- K982414: Gambro Polyflux 11S, 14S, 17S & 21S Hemodialyzers/ Hemofilters (1999), 36 descendants of its own
- K030592: Gambro Polyflux, Model 140H, 170H, 210H (2003), 19 descendants of its own
- K040255: Polyflux 14L, 17L, 21L Hemodialyzer/Filter Labeled for Single Use (2004), 10 descendants of its own
- K994390: Gambro Polyflux 17R, Capillary Dialyzer/ Filter (2000), 10 descendants of its own
- K043342: Polyflux Family Hemodialyzer/Filter Labeled for Single and Multiple Use, Models 14L, 17L, 21L, 140H, 170H, 210H,6LR, 8LR (2005), 9 descendants of its own

## Indications for use
The Centrysystem 14 PES Gamma 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/K955592
Methodology: https://510kreport.com/methodology