510(k) Report

Devices descending from K000842

16 later devices reach Cadd-Prizm PCS II Model 6101 Ambulatory Infusion System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K123049Sapphire Infusion PumpQ Core Medical, Ltd.20137—
+1K042228Beeline Motiv, Propolis, PcaMckinley, Inc.20047—
+2K192860Sapphire Infusion Pump, Sapphire administration setsQ Core Medical, Ltd.20201Class I
+2K171346Sapphire SetsIcu Medical201709
+2K160492Hospira Sapphire SetsHospira, Inc.20160—
+2K141389Sapphire Infusion PumpQ Core Medical, Ltd.20143—
+2K141834Sapphire Administration SetQ Core Medical, Ltd.20140—
+2K050770Modification to Accufuser, Accufuser Plus Standard Procedure KitMckinley Medical, LLC20056—
+3K213744Avoset Infusion Pump SystemEitan Medical, Ltd.20230—
+3K161667Sapphire Infusion PumpQ Core Medical, Ltd.20172—
+3K081905Accuflow and Accuflux Elastomeric Infusion PumpWestmed, Inc.20084Class I
+3K052451MPS Acacia Medflo Elastomeric PumpMps Acacia20055—
+4K151650SMARTez elastomeric infusion pumpEpic Medical Pte., Ltd.20163—
+5K250234SMARTeZ™ Elastomeric Infusion Pump (RS series)Epic Medical Pte., Ltd.20260—
+5K240624InfuLifeFirst Medical Source, LLC20240—
+5K242152SMARTeZ™ Elastomeric Infusion Pump (498111, 498121, 498131, 498141)Epic Medical Pte., Ltd.20240—