510(k) Report

Devices descending from K990461

9 later devices reach Mckinley SP Disposable Infusion Pump through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K032642Beeline SystemMckinley, Inc.20038—
+2K042228Beeline Motiv, Propolis, PcaMckinley, Inc.20047—
+3K050770Modification to Accufuser, Accufuser Plus Standard Procedure KitMckinley Medical, LLC20056—
+4K081905Accuflow and Accuflux Elastomeric Infusion PumpWestmed, Inc.20084Class I
+4K052451MPS Acacia Medflo Elastomeric PumpMps Acacia20055—
+5K151650SMARTez elastomeric infusion pumpEpic Medical Pte., Ltd.20163—
+6K250234SMARTeZ™ Elastomeric Infusion Pump (RS series)Epic Medical Pte., Ltd.20260—
+6K240624InfuLifeFirst Medical Source, LLC20240—
+6K242152SMARTeZ™ Elastomeric Infusion Pump (498111, 498121, 498131, 498141)Epic Medical Pte., Ltd.20240—