Radiometer Medicals Aps - FDA 510(k) Cleared Devices

Radiometer Medicals Aps, is a global provider of acute care testing solutions with a manufacturing facility in Brønshøj, Denmark. The company specializes in blood gas analyzers, immunoassay testing, and point-of-care diagnostic systems for hospitals and clinical laboratories.

Radiometer has received 5 FDA 510(k) clearances from 5 total submissions, with all submissions focused on Chemistry devices. The company's first FDA clearance was in 2024, with the most recent clearance in 2026, demonstrating continued regulatory activity and product innovation in acute care diagnostics.

The company's cleared devices include the ABL90 FLEX PLUS System and related configurations, which deliver rapid blood gas results with multiple parameters. Radiometer has operated as a market leader in blood gas testing since 1954 and continues to support critical care workflows across emergency departments, intensive care units, and neonatal settings.

Explore the complete list of device names, product codes, and clearance dates in the 510(k) database.

1 device has linked clinical trial registered on ClinicalTrials.gov.