Model note · Haemodialysis Machine
Baxter (Vantive) AK 98 Dialysis Machine
The AK 98 is a standalone, software controlled haemodialysis machine from the Gambro line, used in chronic dialysis units and hospitals for intermittent haemodialysis and isolated ultrafiltration in patients of 25 kg or more. It has a fluid unit that mixes dialysis fluid from RO water and concentrate or BiCart powder, a blood unit with blood pump and heparin pump, and a touch screen panel. In the US the U9000 ultrafilter is a required part of the system to keep dialysis fluid microbiologically clean.
The model
Maker, model and type.
- Maker
- Baxter Healthcare Corporation (kidney care business now Vantive US Healthcare)
- Model
- AK 98 Dialysis Machine (product code 955607) with U9000 Ultrafilter
- Device type
- Haemodialysis Machine
- Main document
- Open the public document
Key specifications
What the public record says.
| Item | Value | Source |
|---|---|---|
| Blood flow rate | 20 to 600 mL/min; accuracy plus or minus 10 mL/min or 10% of set value, whichever is larger, for pre pump pressure of -200 to 0 mmHg | Source |
| Dialysis fluid flow rate | 300 to 800 mL/min; accuracy plus or minus 10% or 50 mL/min, whichever is larger | Source |
| Net fluid removal rate | 0 to 4 L/h; UF accuracy between plus or minus 50 and 100 g/h depending on UF rate | Source |
| Dialysis fluid temperature | 33 to 40 degrees C | Source |
| Dialysis fluid conductivity set range | 9 to 16 mS/cm, with sodium and bicarbonate profiling | Source |
| Pressure limits | Arterial -400 to +300 mmHg; venous +10 to +500 mmHg; TMP -200 to +500 mmHg (calculated) | Source |
| Heparin pump | 0 to 10.0 mL/h continuous, bolus 0 to 10.0 mL | Source |
| Disinfection | Heat and chemical programs | Source |
| Treatment modes | Double needle, and single needle with one pump (double clamp) or the C-705 expansion chamber; isolated UF; Diascan clearance measurement | Source |
| FDA clearance | K201809, 10 March 2021, product code KDI, 21 CFR 876.5860, predicate Gambro Phoenix (K103832) | Source |
Recalls
Known FDA recalls.
- Z-0327-20252024-10-16
Correction on possible exposure to non dioxin like PCBs and PCBAs from internal tubing in newer machines.
FDA record
Safety
Safety warnings from the record.
- Not for self care or home use, and only for patients weighing 25 kg or more. Source
- With the C-705 chamber, the total extracorporeal volume should stay under 10% of the patient's blood volume. Source
- On a fault the machine enters a patient safe state, which can include bypassing the dialyser; staff must resolve the alarm before resuming. Source
Sources
Where this note comes from.
- FDA 510(k) K201809 summary, Baxter AK 98 Dialysis Machine, U9000, C-705
- FDA recall Z-0327-2025, AK 98
- openFDA MAUDE problem counts, brand AK 98
Not covered: The AK 98 operator's and service manuals are not public, so alarm codes, calibration procedures and part numbers are not given beyond the valve names in a MAUDE report. The 510(k) comparison table extracts with shifted columns; values were matched carefully but should be checked against the operator's manual. The manufacturerUrl points to the FDA summary because no Vantive product page was opened.
BMEssentia knowledge drafted from public information, reviewed by Hasan Khaled Ismail on 2026-10-24. Always follow the manufacturer's instructions for use and service manual.
Haemodialysis Machine
Other models of this device.
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