# K051520: Gambro Polyflux Hemodialyzer, Model 6H

- Pathway: 510(k) (Traditional)
- Applicant: Gambro Renal Products
- Decided: Dec 9, 2005 after 184 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: 3 generations back to K955592 (1997). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030592: Gambro Polyflux, Model 140H, 170H, 210H, Gambro Renal Care Products (2003). Our OCR of the scanned summary read K030392, FDA’s number for Sapphire Detachable Coil System (Micro Therapeutics, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Polyflux 140H, 170H, 210H Hemodialyzer / Filter”.
- K904566: New Cobe Centrysystem (TM) 100 HG Dialyzer, Cobe Laboratories, Inc. (1990). Our OCR of the scanned summary read K904560, FDA’s number for Valleylab Laparoscopic Handswitch/Electrodes (Valleylab, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “100 HG Hemodialyzer / Filter”.

## Most influential descendants
- K160558: Rapido Hollow-Fibre Dialyzers (2016), 0 descendants of its own

## Indications for use
The Polyflux 6H is intended for chronic and acute applications in hemodialysis, hemodiafiltration and hemofiltration on small patients including pediatric indications, considering blood flow, body weight and extracorporeal blood volume.

Source page: https://510kreport.com/device/K051520
Methodology: https://510kreport.com/methodology