510(k) Report

Devices descending from K991513

21 later devices reach Homepump C-Series and Homepump C-Series One-Step Kvo through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K151650SMARTez elastomeric infusion pumpEpic Medical Pte., Ltd.20163—
+1K020862I-Flow Elastomeric PumpI-Flow Corp.2002191
+1K020660Homepump, Eclipse, C-Series, Painbuster, C-Bloc, on-Q, Easypump, One Step KvoI-Flow Corp.20020—
+2K250234SMARTeZ™ Elastomeric Infusion Pump (RS series)Epic Medical Pte., Ltd.20260—
+2K240624InfuLifeFirst Medical Source, LLC20240—
+2K242152SMARTeZ™ Elastomeric Infusion Pump (498111, 498121, 498131, 498141)Epic Medical Pte., Ltd.20240—
+2K023098Accufuser, Accufuser Plus, Standard Procedure Kit, Accufuser Infusion KitMckinley Infuser200217—
+2K023318I-Flow Elastomeric Pump with BolusI-Flow Corp.20020Class I
+3K053226Zimmer Ambulatory Pump Pain Management Systems with Fenestrated Catheter and Flow SplitterZimmer, Inc.20060—
+3K033039Modification to: Accufuser, Accufuser Plus, Standard Procedure KitsMckinley, Inc.200315—
+3K032642Beeline SystemMckinley, Inc.20038—
+4K060258AutofuserAce Medical Us, LLC2006146
+4K050433Zimmer Ambulatory Pump Pain Management SystemZimmer Orthopaedic Surgical Products20052—
+4K042228Beeline Motiv, Propolis, PcaMckinley, Inc.20047—
+4K042246Multi-Drip Infusion CatheterAdvanced Infusion, Inc.20041—
+5K090300Modification to AutofuserAce Medical Us, LLC2009016
+5K061356Polyurethane Infusion Catheter, Alpha Cath, Model PAC20, and Polyurethane Infusion…Advanced Infusion, Inc.20060—
+5K052171Zimmer Ambulatory Pump Pain Management System with Patient Control ModuleZimmer, Inc.20051—
+5K050770Modification to Accufuser, Accufuser Plus Standard Procedure KitMckinley Medical, LLC20056—
+6K081905Accuflow and Accuflux Elastomeric Infusion PumpWestmed, Inc.20084Class I
+6K052451MPS Acacia Medflo Elastomeric PumpMps Acacia20055—