510(k) Report

Devices descending from K060479

11 later devices reach Modification to Bodyguard Infusion Pump System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K123049Sapphire Infusion PumpQ Core Medical, Ltd.20137—
+1K090087Mridium 3860 Mri Infusion Pump/Monitoring SystemIradimed Corporation20092Class I
+2K192860Sapphire Infusion Pump, Sapphire administration setsQ Core Medical, Ltd.20201Class I
+2K171346Sapphire SetsIcu Medical201709
+2K143369MRidium 3860+ MRI infusion Pump/ Monitoring SystemIradimed Corporation201611
+2K160492Hospira Sapphire SetsHospira, Inc.20160—
+2K141389Sapphire Infusion PumpQ Core Medical, Ltd.20143—
+2K141834Sapphire Administration SetQ Core Medical, Ltd.20140—
+3K242752MRidium 3870 MRI Infusion Pump System (3870)Iradimed Corporation20250—
+3K213744Avoset Infusion Pump SystemEitan Medical, Ltd.20230—
+3K161667Sapphire Infusion PumpQ Core Medical, Ltd.20172—