510(k) Report

Devices descending from K884505

25 later devices reach Basal/Bolus Infusors through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K992072Bolus Accessory SetI-Flow Corp.199921—
+1K984638Paragon Bolus Accessory SetI-Flow Corp.199924—
+2K020862I-Flow Elastomeric PumpI-Flow Corp.2002191
+2K020660Homepump, Eclipse, C-Series, Painbuster, C-Bloc, on-Q, Easypump, One Step KvoI-Flow Corp.20020—
+2K020251Paragon Infusion SystemI-Flow Corp.20028—
+3K052451MPS Acacia Medflo Elastomeric PumpMps Acacia20055—
+3K023883Homepump, Eclipse, C-Series, Painbuster, C-Bloc, on-Q, Easypump, KvoI-Flow Corp.20020—
+3K023098Accufuser, Accufuser Plus, Standard Procedure Kit, Accufuser Infusion KitMckinley Infuser200217—
+3K023318I-Flow Elastomeric Pump with BolusI-Flow Corp.20020Class I
+4K081905Accuflow and Accuflux Elastomeric Infusion PumpWestmed, Inc.20084Class I
+4K053226Zimmer Ambulatory Pump Pain Management Systems with Fenestrated Catheter and Flow SplitterZimmer, Inc.20060—
+4K033039Modification to: Accufuser, Accufuser Plus, Standard Procedure KitsMckinley, Inc.200315—
+4K032642Beeline SystemMckinley, Inc.20038—
+5K151650SMARTez elastomeric infusion pumpEpic Medical Pte., Ltd.20163—
+5K060258AutofuserAce Medical Us, LLC2006146
+5K050433Zimmer Ambulatory Pump Pain Management SystemZimmer Orthopaedic Surgical Products20052—
+5K042228Beeline Motiv, Propolis, PcaMckinley, Inc.20047—
+5K042246Multi-Drip Infusion CatheterAdvanced Infusion, Inc.20041—
+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—
+6K090300Modification to AutofuserAce Medical Us, LLC2009016
+6K061356Polyurethane Infusion Catheter, Alpha Cath, Model PAC20, and Polyurethane Infusion…Advanced Infusion, Inc.20060—
+6K052171Zimmer Ambulatory Pump Pain Management System with Patient Control ModuleZimmer, Inc.20051—
+6K050770Modification to Accufuser, Accufuser Plus Standard Procedure KitMckinley Medical, LLC20056—