# K070643: Phoenix Hemodialysis Delivery System, Version 3.35

- Pathway: 510(k) (Traditional)
- Applicant: Gambro, Inc.
- Decided: Nov 2, 2007 after 239 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
No predicates in its family tree.
7 later devices descend from it; 2 cite it directly.
1 of 8 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. Our reading found no predicate number; beside “510(k)” the summary prints a number our reading could not make out (“10810”).
- (no number) Phoenix® Hemodialysis Delivery System Version 3.00: named in the summary without a submission number

## Most influential descendants
- K103832: Phoenix Hemodialysis Delivery System (2011), 4 descendants of its own
- K201809: AK 98 Dialysis Machine, U9000 Ultrafilter, C705 Expansion Chamber Accessory (2021), 3 descendants of its own
- K232467: CleanCart A, CleanCart C, AK 98 Hemodialysis Machine (2023), 1 descendant of its own
- K103242: Redsense-Alarm Unit and Sensor (2011), 1 descendant of its own
- K250508: AK 98 Dialysis Machine (955607) (2025), 0 descendants of its own

## Indications for use
The Phoenix® Hemodialysis delivery system is intended to be used to provide high flux and low flux hemodialysis, hemofiltration and ultrafiltration on patients weighing 15 Kilograms or more. The Phoenix system is to be used with either high or low permeability dialyzers. The device is intended to be used by trained operators when prescribed by a physician, in a chronic care dialysis facility or acute care unit.

Source page: https://510kreport.com/device/K070643
Methodology: https://510kreport.com/methodology