ULTRAFILTRATION CONTROLLER— 510(k) K832547

Substantially Equivalent

Extracorporeal Medical Specialities, Inc.

FDA 510(k) clearance K832547 for ULTRAFILTRATION CONTROLLER, Substantially Equivalent on 1984-01-03. Applicant: Extracorporeal Medical Specialities, Inc..

Clearance details

Applicant: Extracorporeal Medical Specialities, Inc.
Product code: Code KDI
Advisory panel: Gastroenterology, Urology
Date received: 1983-08-01
Decision date: 1984-01-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, 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.