ACDS— 510(k) K120005

Substantially Equivalent

Isopure, Corp.

FDA 510(k) clearance K120005 for ACDS, Substantially Equivalent on 2012-03-29. Applicant: Isopure, Corp..

Clearance details

Applicant: Isopure, Corp.
Product code: Code KPO
Advisory panel: Gastroenterology, Urology
Date received: 2012-01-03
Decision date: 2012-03-29
Decision: Substantially Equivalent
Clearance type: Special
Location: Simpsonville, KY, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KPO

product code KPO

Death: 14
Malfunction: 775
Other: 20
Total: 809

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.