Rio Vial-to-Bag Drug Reconstitution Device— 510(k) K192154

Substantially Equivalent

Icu Medical

FDA 510(k) clearance K192154 for Rio Vial-to-Bag Drug Reconstitution Device, Substantially Equivalent on 2020-04-20. Applicant: Icu Medical.

Clearance details

Applicant: Icu Medical
Product code: Code LHI
Advisory panel: General Hospital
Date received: 2019-08-09
Decision date: 2020-04-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Clemente, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LHI

product code LHI

Injury: 207
Malfunction: 7,820
Other: 3
Total: 8,030

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.