510(k) Report

Devices descending from K091308

5 later devices reach Alaris PC Unit, Models 8000 and 8015 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K133532Alaris System with Guardrails Suite MXCarefusion 303, Inc.20143Class I
+1K110535Alaris PC Unit Module 8000 with Software CorrectionCarefusion 303, Inc.20120—
+2K211218BD Alaris System with Guardrails Suite MX v12.1.2Carefusion 303, Inc.20231Class I
+2K210074Agilia SP Infusion System, Agilia SP MC WIFI Infusion Pump, Agilia Link, Agilia Duo…Fresenius Kabi AG20220—
+3K243855BD Alaris Infusion System with Guardrails Suite MXCarefusion 303, Inc.20250—