510(k) Report

Devices descending from K040337

18 later devices reach I-Flow Elastomeric Pump (on-Q, Painbuster, C-Bloc, Homepump) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K060933Solace Post-Operative Pain Relief Infusion SystemApex Medical Technologies, Inc.20060—
+1K052117I-Flow Elastomeric Pump (on-Q, Painbuster, C-Block, Homepump, Easypump)I-Flow Corp.200593
+1K043466PAINPUMP2Stryker Instruments2005172
+1K050770Modification to Accufuser, Accufuser Plus Standard Procedure KitMckinley Medical, LLC20056—
+1K042228Beeline Motiv, Propolis, PcaMckinley, Inc.20047—
+1K042405PAINPUMP1; PAINPUMP2Stryker Corp.2004370
+2K151650SMARTez elastomeric infusion pumpEpic Medical Pte., Ltd.20163—
+2K081905Accuflow and Accuflux Elastomeric Infusion PumpWestmed, Inc.20084Class I
+2K072702Stryker Antimic CatheterStryker Instruments, Instruments Div.20080—
+2K063530ON-Q, Painbuster, C-Bloc, Select-a-Flow, Ondemand, Homepump, Eclipse, C-Series, One-Step…I-Flow Corp.200733
+2K052221Ambit Push & Play Ambulatory Infusion PumpSorenson Medical, Inc.200504
+2K052451MPS Acacia Medflo Elastomeric PumpMps Acacia20055—
+3K250234SMARTeZ™ Elastomeric Infusion Pump (RS series)Epic Medical Pte., Ltd.20260—
+3K240624InfuLifeFirst Medical Source, LLC20240—
+3K242152SMARTeZ™ Elastomeric Infusion Pump (498111, 498121, 498131, 498141)Epic Medical Pte., Ltd.20240—
+3K181360ON-Q* Pump with BolusHalyard Health20190—
+3K131247Multibolus II Disposable Pain Management SystemMfs - Medical Flow Systems, Ltd.20130—
+3K072053Smartblock Pain PumpMedical Flow Systems, Ltd.200702