# K250508: AK 98 Dialysis Machine (955607)

- Pathway: 510(k) (Traditional)
- Applicant: Vantive US Healthcare, LLC
- Decided: Aug 1, 2025 after 161 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
Longest line of descent: 4 generations back to K070643 (2007). 7 ancestors in all.
No later device cites it as a predicate yet.
1 of 8 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K232467: CleanCart A, CleanCart C, AK 98 Hemodialysis Machine, Baxter Healthcare Corporation (2023) Summary page 6.

## Indications for use
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/K250508
Methodology: https://510kreport.com/methodology