510(k) Report

Devices descending from K052117

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K151650SMARTez elastomeric infusion pumpEpic Medical Pte., Ltd.20163—
+1K081905Accuflow and Accuflux Elastomeric Infusion PumpWestmed, Inc.20084Class I
+1K063530ON-Q, Painbuster, C-Bloc, Select-a-Flow, Ondemand, Homepump, Eclipse, C-Series, One-Step…I-Flow Corp.200733
+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—
+2K181360ON-Q* Pump with BolusHalyard Health20190—
+2K131247Multibolus II Disposable Pain Management SystemMfs - Medical Flow Systems, Ltd.20130—
+2K072053Smartblock Pain PumpMedical Flow Systems, Ltd.200702