SC+ Hemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tubeset— 510(k) K210661

Substantially Equivalent

Quanta Dialysis Technologies, Ltd.

FDA 510(k) clearance K210661 for SC+ Hemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tubeset, Substantially Equivalent on 2021-08-12. Applicant: Quanta Dialysis Technologies, Ltd..

Clearance details

Applicant: Quanta Dialysis Technologies, Ltd.
Product code: Code KDI
Advisory panel: Gastroenterology, Urology
Date received: 2021-03-04
Decision date: 2021-08-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Alcester, GB

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.