510(k) Report

Devices descending from K982946

42 later devices reach Painbuster Infusion Kit through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K060258AutofuserAce Medical Us, LLC2006146
+1K060933Solace Post-Operative Pain Relief Infusion SystemApex Medical Technologies, Inc.20060—
+1K042122Smartinfuser PainpumpPrecise Medical Products200411
+1K990425Sidekick Infusion KitI-Flow Corp.19990—
+1K984502Nerve Block Infusion KitI-Flow Corp.199933—
+1K984146Paragon InfusionI-Flow Corp.199911—
+1K984063Paragon Basal/Bolus Administration SetI-Flow Corp.19999—
+2K090300Modification to AutofuserAce Medical Us, LLC2009016
+2K061409Smartinfuser Painpump, Model P49220 W/Catheter Set; P49224N W/O Catheter SetPrecise Medical Products, Ltd.200602
+2K043204Sgarlato Labs Painfree Pump and Pain Control Infusion PumpSgarlato Laboratories, Inc.20050—
+2K030830B. Braun Nerve Block CatheterB.Braun Medical, Inc.200310—
+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—
+3K042488Perifix Catheter and Contiplex CatheterB.Braun Medical, Inc.20049—
+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
+4K153297Perifix and Contiplex CatheterB.Braun Medical, Inc.20160—
+4K150731Medline Epidural CatheterMedline Industries, Inc.20160—
+4K102594IO-Flex CatheterBaxano, Inc.20110—
+4K090884Perifix One Pediatric Catheter, 20 GA. & 24 GA.B.Braun Medical, Inc.20090—
+4K081905Accuflow and Accuflux Elastomeric Infusion PumpWestmed, Inc.20084Class I
+4K053226Zimmer Ambulatory Pump Pain Management Systems with Fenestrated Catheter and Flow SplitterZimmer, Inc.20060—
+4K050557Amt NanocathAmerican Medical Technologies, Inc.20050—
+4K043500Functional Anaesthetic Discography (Fad) System, Including Fad Catheter Kit and Fad…Innospine, Inc.200531
+4K033039Modification to: Accufuser, Accufuser Plus, Standard Procedure KitsMckinley, Inc.200315—
+4K032642Beeline SystemMckinley, Inc.20038—
+5K151650SMARTez elastomeric infusion pumpEpic Medical Pte., Ltd.20163—
+5K073516Discyphor Direct Catheter System, Discyphor Direct Needles, Long, Discyphor Direct…Kyphon, Inc.20080—
+5K063071Discyphor Catheter System, Model D01A; Discyphor Introducer Needle, Model D01BKyphon, Inc.20071—
+5K061210Functional Anaesthetic Discography (Fad) Catheter System, Model D01A ; Introducer…Kyphon, Inc.20062—
+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—
+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—