# K232467: CleanCart A, CleanCart C, AK 98 Hemodialysis Machine

- Pathway: 510(k) (Special)
- Applicant: Baxter Healthcare Corporation
- Decided: Sep 14, 2023 after 30 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 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K070643 (2007). 6 ancestors in all.
1 later device descends from it; 1 cites 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)
- K001156: Phoenix Hemodialysis Delivery System, Gambro Cartridge for Hemodialysis Blood Tubing Set, Gambro Renal Products (2000) Summary page 5.
- K201809: AK 98 Dialysis Machine, U9000 Ultrafilter, C705 Expansion Chamber Accessory, Baxter Healthcare Corportation (2021) Summary page 5.

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

## Recalls of this device
- Oct 16, 2024 · Class I · Z-0327-2025: Baxter is aware of several recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (P

## Indications for use
The CleanCart A cartridge is intended for preparation of a sodium carbonate solution used for removing organic deposits, fats and proteins from the dialysis machine’s fluid circuit. The CleanCart A cartridge must be used in combination with the heat disinfection program of the corresponding dialysis machine. The CleanCart C cartridge is intended for preparation of a citric acid solution used for removing calcium and magnesium precipitation from the dialysis machine’s fluid circuit. The CleanCart C cartridge must be used in combination with the heat disinfection program of the corresponding dialysis machine The Baxter AK 98 Dialysis machine is intended to be used for intermittent hemodialysis and/or isolated ultrafiltration treatments of patients with chronic or acute renal failure or fluid overload upon prescription by a physician. The AK 98 Dialysis Machine is indicated to be used on patients with a body weight of 25 kg or more. The AK 98 Dialysis Machine is intended to be used by trained operators when prescribed by a physician, in a chronic care dialysis or hospital care environment. The Baxter AK 98 Dialysis Machine is not intended for Selfcare or home use.

Source page: https://510kreport.com/device/K232467
Methodology: https://510kreport.com/methodology