# K211035: U9000 Plus Ultrafilter

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare Corporation
- Decided: Oct 19, 2021 after 195 days
- Product code: FIP (Subsystem, Water Purification)
- Device class: 2
- Regulation: 21 CFR 876.5665
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K070643 (2007). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201809: AK 98 Dialysis Machine, U9000 Ultrafilter, C705 Expansion Chamber Accessory, Baxter Healthcare Corportation (2021) Summary page 4.

## Indications for use
The U9000 Plus 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 Plus Ultrafilter is intended to be used in conjunction with a water treatment system. WARNING! The U9000 Plus Ultrafilter can only be used with AK98 dialysis machines equipped with holder for an ultrafilter.

Source page: https://510kreport.com/device/K211035
Methodology: https://510kreport.com/methodology