DIMI RRT System— 510(k) K193005

Name: FDA 510(k) clearance K193005
Creator: U.S. Food and Drug Administration
Published: 2020-08-28

Substantially Equivalent

Dialco Medical, Inc.

FDA 510(k) clearance K193005 for DIMI RRT System, Substantially Equivalent on 2020-08-28. Applicant: Dialco Medical, Inc.. Device class: 2.

Clearance details

Applicant: Dialco Medical, Inc.
Product code: Code KDI
Device class: Class 2
Regulation: 21 CFR 876.5860
Advisory panel: Gastroenterology, Urology
Date received: 2019-10-28
Decision date: 2020-08-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Toronto, CA

Download summary PDF View on FDA.gov ↗

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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.