# K955487: Gambro Polyflux 14, 17, & 21 Hemodialyzers

- Pathway: 510(k) (Traditional)
- Applicant: Cobe Renal Care, Inc.
- Decided: Apr 18, 1997 after 504 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 K933818 (1995). 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)
- K933818: Gambro Polyflux II Hemodialyzerialyzer Hemodiafilter, C.G.H. Medical, Inc. (1995) Summary page 1.

## Indications for use
The Gambro Polyflux 14, 17, and 21 hemodialyzers 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/K955487
Methodology: https://510kreport.com/methodology