510(k) Report

Devices descending from K133532

3 later devices reach Alaris System with Guardrails Suite MX through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K211218BD Alaris System with Guardrails Suite MX v12.1.2Carefusion 303, Inc.20231Class I
+1K210074Agilia SP Infusion System, Agilia SP MC WIFI Infusion Pump, Agilia Link, Agilia Duo…Fresenius Kabi AG20220—
+2K243855BD Alaris Infusion System with Guardrails Suite MXCarefusion 303, Inc.20250—