510(k) Report

Devices descending from K043218

4 later devices reach ABL800 Flex with Flexq Module, Model ABL8XX through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K151639ABL80 FLEX and ABL80 FLEX CO-OXSendx Medical, Inc.20150—
+1K073537Neonatal Bilirubin on Rapidlab Models 1245 and 1265Siemens Medical Solutions Diagnostics200817
+1K051968ABL8X7 FlexRadiometer Medical Aps200604
+2K110277Rapidpoint 405 Neonatal BilirubinSiemens Healthcare Diagnostics201105