# K201809: AK 98 Dialysis Machine, U9000 Ultrafilter, C705 Expansion Chamber Accessory

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare Corportation
- Decided: Mar 10, 2021 after 252 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: 2 generations back to K070643 (2007). 4 ancestors in all.
3 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)
- K103832: Phoenix Hemodialysis Delivery System, Gambro Renal Products, Inc. (2011) Summary page 8.
- K003957: Diaclear Ultrafilter, Gambro Renal Products (2001) Summary page 8.
- K070414: Gambro Cartridge Blood Sets, Gambro Renal Products (2007) Summary page 8.

## Most influential descendants
- 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

## Indications for use
The Baxter AK 98 dialysis machine is intended to be used for intermittant haemodialysis 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. C-705 Accessory Expansion Chamber is a single use sterile medical device intended to be used during the delivery of Hemodialysis treatment in Single Needle mode, on patients affected by chronic renal failure. The C-705 Accessory Expansion Chamber is an ancillary device used to allow the conversion from Double Needle to Single Needle administration mode of treatments, after connection to proper Blood Tubing System intended for Haemodialysis treatment in Double Needle mode and to a Dialyzer filter. C-705 Accessory Expansion Chamber shall be used in combination with Blood Tubing System suitable for AK 98 haemodialysis delivery system only. The total extracorporeal blood volume for the extracorporeal circuit including the set, dialyzer and accessories should represent less than 10% of the patient’s blood volume. The U9000 Ultrafilter is indicated for purification of incoming water for dialysis fluid as well as purification of dialysis fluid to obtain standard dialysis fluid in accordance with international standards requirements and local regulations. The risk of exposure to bacteria and endotoxins can thereby be minimized. The U9000 Ultrafilter is intended to be used in conjunction with a water treatment system.

Source page: https://510kreport.com/device/K201809
Methodology: https://510kreport.com/methodology