# K982414: Gambro Polyflux 11S, 14S, 17S & 21S Hemodialyzers/ Hemofilters

- Pathway: 510(k) (Traditional)
- Applicant: Gambro Healthcare
- Decided: Mar 26, 1999 after 256 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.
36 later devices descend from it; 5 cite it directly.
0 of 38 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 1.

## Most influential descendants
- 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
- K014152: Nxstage Cartridge Express (2002), 7 descendants of its own

## Indications for use
The Gambro Polyflux 118, 14S, 17S, and 21S hemodialyzers / filters can be used whenever hemodialysis or hemofiltration is indicated. These can be used for acute or chronic hemodialysis or hemofiltration. In these therapies, monitoring of patient vital signs, the therapy delivery system, heparin administration and clotting times should be performed under the supervision / direction of a physician.

Source page: https://510kreport.com/device/K982414
Methodology: https://510kreport.com/methodology