# K103832: Phoenix Hemodialysis Delivery System

- Pathway: 510(k) (Traditional)
- Applicant: Gambro Renal Products, Inc.
- Decided: May 20, 2011 after 141 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: 1 generation back to K070643 (2007). 1 ancestor in all.
4 later devices descend from it; 1 cites it directly.
1 of 6 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070643: Phoenix Hemodialysis Delivery System, Version 3.35, Gambro, Inc. (2007) Summary page 1.

## Most influential descendants
- 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
- K250508: AK 98 Dialysis Machine (955607) (2025), 0 descendants of its own
- K211035: U9000 Plus Ultrafilter (2021), 0 descendants of its own

## Recalls of this device
- Jan 4, 2017 · Class II · Z-1094-2017: Baxter Healthcare Corporation is issuing a voluntary product recall for several lots of Phoenix Dialysis Machine Preventive Maintenance Kits due to incorrect silicone straight connectors components pa
- Jan 4, 2017 · Class II · Z-1095-2017: Baxter Healthcare Corporation is issuing a voluntary product recall for several lots of Phoenix Dialysis Machine Preventive Maintenance Kits due to incorrect silicone straight connectors components pa

## Indications for use
The Phoenix® Hemodialysis delivery system is intended to be used to provide high flux and low flux hemodialysis, hemnofiltration 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/K103832
Methodology: https://510kreport.com/methodology