510(k) Report

Devices descending from K110416

5 later devices reach ABL835 Flex Analyzer with Pleural PH through their predicates, nearest generation first.

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