510(k) Report

Devices descending from K895317

16 later devices reach Avl Model 995HB PH/Blood Gas Analyzer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K052027Opti Lion Electrolyte Analyzer, Model GD7200Osmetech, Inc.200504
+1K050423Omni Modular, Omni C and Omni S Analyzer (PH Electrode)Roche Diagnostics20057—
+1K984299Avl Opti Critical Care AnalyzerAvl Scientific Corp.19984—
+1K974784Avl Opti Critical Care AnalyzerAvl Scientific Corp.19985—
+1K963964Avl Compact 3 PH/Blood Gas AnalyzerAvl Scientific Corp.19960—
+1K961161Avl Opti 1 PH/Blood Gas AnalyzerAvl Scientific Corp.19966—
+2K110416ABL835 Flex Analyzer with Pleural PHRadiometer Medical Aps201152
+2K100777ABL837 Flex AnalyzerRadiometer Medical Aps201002
+2K993837Avl Opti Critical Care AnalyzerAvl Scientific Corp.19992—
+3K131126Opti Cca-TS2Opti Medical Systems, Inc.20131—
+3K122539Measurement of PH in Pleural Fluid on Blood Gas SystemSiemens Healthcare Diagnostics20134—
+4K200986OPTI® B-Lac CassetteOpti Medical Systems, Inc.20210—
+4K192240RAPIDPoint 500e Blood Gas SystemSiemens Healthcare Diagnostics, Inc.202034
+5K230285i-STAT CG8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.20230—
+5K223857i-STAT G3+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.202311
+6K244014i-STAT CG4+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.202501