EASY CARE AND TUBING SETS— 510(k) K994218

Substantially Equivalent

Medionics International, Inc.

FDA 510(k) clearance K994218 for EASY CARE AND TUBING SETS, Substantially Equivalent on 2000-02-10. Applicant: Medionics International, Inc..

Clearance details

Applicant: Medionics International, Inc.
Product code: Code FKX
Advisory panel: Gastroenterology, Urology
Date received: 1999-12-15
Decision date: 2000-02-10
Decision: Substantially Equivalent
Clearance type: Special
Location: Markham, Ontario, CA

Download summary PDF View on FDA.gov ↗

Adverse events under product code FKX

product code FKX

Death: 501
Injury: 6,720
Malfunction: 18,508
Other: 1
Total: 25,730

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.