510(k) Report

Devices descending from K033039

15 later devices reach Modification to: Accufuser, Accufuser Plus, Standard Procedure Kits through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K060258AutofuserAce Medical Us, LLC2006146
+1K053226Zimmer Ambulatory Pump Pain Management Systems with Fenestrated Catheter and Flow SplitterZimmer, Inc.20060—
+1K050433Zimmer Ambulatory Pump Pain Management SystemZimmer Orthopaedic Surgical Products20052—
+1K042228Beeline Motiv, Propolis, PcaMckinley, Inc.20047—
+1K042246Multi-Drip Infusion CatheterAdvanced Infusion, Inc.20041—
+2K090300Modification to AutofuserAce Medical Us, LLC2009016
+2K061356Polyurethane Infusion Catheter, Alpha Cath, Model PAC20, and Polyurethane Infusion…Advanced Infusion, Inc.20060—
+2K052171Zimmer Ambulatory Pump Pain Management System with Patient Control ModuleZimmer, Inc.20051—
+2K050770Modification to Accufuser, Accufuser Plus Standard Procedure KitMckinley Medical, LLC20056—
+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—