510(k) Report

Devices descending from K050423

7 later devices reach Omni Modular, Omni C and Omni S Analyzer (PH Electrode) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K110416ABL835 Flex Analyzer with Pleural PHRadiometer Medical Aps201152
+1K100777ABL837 Flex AnalyzerRadiometer Medical Aps201002
+2K122539Measurement of PH in Pleural Fluid on Blood Gas SystemSiemens Healthcare Diagnostics20134—
+3K192240RAPIDPoint 500e Blood Gas SystemSiemens Healthcare Diagnostics, Inc.202034
+4K230285i-STAT CG8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.20230—
+4K223857i-STAT G3+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.202311
+5K244014i-STAT CG4+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.202501