510(k) Report

Devices descending from K021480

11 later devices reach Extension Set Light-Safe, Model BC565 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K061771EZ-ConnectVidacare Corporation20060—
+1K041490IV Administration Sets with Ultrablock UV-Resistant TubingB.Braun Medical, Inc.200491
+2K082182AP 34 Multi-Therapy Infusion PumpQ-Core, Ltd.20088—
+3K123049Sapphire Infusion PumpQ Core Medical, Ltd.20137—
+4K192860Sapphire Infusion Pump, Sapphire administration setsQ Core Medical, Ltd.20201Class I
+4K171346Sapphire SetsIcu Medical201709
+4K160492Hospira Sapphire SetsHospira, Inc.20160—
+4K141389Sapphire Infusion PumpQ Core Medical, Ltd.20143—
+4K141834Sapphire Administration SetQ Core Medical, Ltd.20140—
+5K213744Avoset Infusion Pump SystemEitan Medical, Ltd.20230—
+5K161667Sapphire Infusion PumpQ Core Medical, Ltd.20172—