510(k) Report

Devices descending from K031749

9 later devices reach Bodyguard Infusion System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K141834Sapphire Administration SetQ Core Medical, Ltd.20140—
+1K082182AP 34 Multi-Therapy Infusion PumpQ-Core, Ltd.20088—
+2K123049Sapphire Infusion PumpQ Core Medical, Ltd.20137—
+3K192860Sapphire Infusion Pump, Sapphire administration setsQ Core Medical, Ltd.20201Class I
+3K171346Sapphire SetsIcu Medical201709
+3K160492Hospira Sapphire SetsHospira, Inc.20160—
+3K141389Sapphire Infusion PumpQ Core Medical, Ltd.20143—
+4K213744Avoset Infusion Pump SystemEitan Medical, Ltd.20230—
+4K161667Sapphire Infusion PumpQ Core Medical, Ltd.20172—