# K001156: Phoenix Hemodialysis Delivery System, Gambro Cartridge for Hemodialysis Blood Tubing Set

- Pathway: 510(k) (Abbreviated)
- Applicant: Gambro Renal Products
- Decided: Jul 7, 2000 after 88 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
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
1 of 3 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K232467: CleanCart A, CleanCart C, AK 98 Hemodialysis Machine (2023), 1 descendant of its own
- K250508: AK 98 Dialysis Machine (955607) (2025), 0 descendants of its own

## Recalls of this device
- Sep 10, 2007 · Not classified · Z-1367-2008: Kinked tubing on hemodialysis device may cause hemolysis.
- May 12, 2006 · Not classified · Z-0200-2007: Defective Heat Exchanger/membrane; this may result in perforation of the membrane thus allowing the presence of infectious organisms and/or pathogens to pass from patient to patient.

Source page: https://510kreport.com/device/K001156
Methodology: https://510kreport.com/methodology