510(k) Report

Devices descending from K192240

3 later devices reach RAPIDPoint 500e Blood Gas System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K230285i-STAT CG8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.20230—
+1K223857i-STAT G3+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.202311
+2K244014i-STAT CG4+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.202501