# K072232: Gambro Polyflux Hemodialyzer, Model: HD-C4 Small

- Pathway: 510(k) (Special)
- Applicant: Gambro Renal Products, Inc.
- Decided: Sep 7, 2007 after 28 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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 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)
- K060195: Gambro Polyflux HD-C4 Capillary Dialyzer/Filter for Single Use, Gambro Renal Products (2006) Summary page 1.

## Most influential descendants
- K130039: Revaclear 300 Dialyzer, Revaclear 400 Dialyzer (2013), 0 descendants of its own

## Recalls of this device
- Apr 16, 2014 · Class II · Z-1643-2014: The firm received several complaints for internal blood leaks involving various lot numbers produced in late 2013.

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

Source page: https://510kreport.com/device/K072232
Methodology: https://510kreport.com/methodology