Digital Dialysis Clinic - Intelligent Dialysis Assistant (IDA) with Medical Supervision Portal and IDA Smartphone App— 510(k) K220935

Substantially Equivalent

Iren-Medical, Ltd.

FDA 510(k) clearance K220935 for Digital Dialysis Clinic - Intelligent Dialysis Assistant (IDA) with Medical Supervision Portal and IDA Smartphone App, Substantially Equivalent on 2022-12-29. Applicant: Iren-Medical, Ltd..

Clearance details

Applicant: Iren-Medical, Ltd.
Product code: Code FKX
Advisory panel: Gastroenterology, Urology
Date received: 2022-03-31
Decision date: 2022-12-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Or Aquiva, IL

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.