# K060195: Gambro Polyflux HD-C4 Capillary Dialyzer/Filter for Single Use

- Pathway: 510(k) (Traditional)
- Applicant: Gambro Renal Products
- Decided: Apr 24, 2006 after 89 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: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K955592 (1997). 4 ancestors in all.
2 later devices descend from it; 2 cite 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) Summary page 1.

## Most influential descendants
- K072232: Gambro Polyflux Hemodialyzer, Model: HD-C4 Small (2007), 1 descendant of its own
- K130039: Revaclear 300 Dialyzer, Revaclear 400 Dialyzer (2013), 0 descendants of its own

## Recalls of this device
- Oct 12, 2016 · Class II · Z-0370-2017: Potential presence of particulate matter on the blood side of the dialyzer
- Apr 16, 2014 · Class II · Z-1644-2014: The firm received several complaints for internal blood leaks involving various lot numbers produced in late 2013.

## Indications for use
The capillary dialyzer is intended for hemodialysis for the treatment of chronic and acute renal failure.

Source page: https://510kreport.com/device/K060195
Methodology: https://510kreport.com/methodology