AK 98 Dialysis Machine, U9000 Ultrafilter, C705 Expansion Chamber Accessory— 510(k) K201809

Substantially Equivalent

Baxter Healthcare Corportation

FDA 510(k) clearance K201809 for AK 98 Dialysis Machine, U9000 Ultrafilter, C705 Expansion Chamber Accessory, Substantially Equivalent on 2021-03-10. Applicant: Baxter Healthcare Corportation.

Clearance details

Applicant: Baxter Healthcare Corportation
Product code: Code KDI
Advisory panel: Gastroenterology, Urology
Date received: 2020-07-01
Decision date: 2021-03-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Round Lake, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KDI

product code KDI

Death: 352
Injury: 1,474
Malfunction: 12,534
Other: 4
Total: 14,364

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.