MEB — Pump, Infusion, Elastomeric Class II

FDA Device Classification

Classification Details

Product Code
MEB
Device Class
Class II
Regulation Number
880.5725
Submission Type
Review Panel
HO
Medical Specialty
General Hospital
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K240624first medical sourceInfuLifeNovember 5, 2024
K242152epic medical pte.SMARTeZ™ Elastomeric Infusion Pump (498111, 498121, 498131, 498141)October 7, 2024
K181360halyard healthON-Q* Pump with BolusMarch 22, 2019
K151650epic medical pte.SMARTez elastomeric infusion pumpApril 4, 2016
K131249i-flowON-Q PAINBUSTER, ON-Q C-BLOC, HOMEPUMP ECLIPSE, HOMEPUMP C-SERIESFebruary 3, 2014
K131247mfs - medical flow systemsMULTIBOLUS II DISPOSABLE PAIN MANAGEMENT SYSTEMAugust 14, 2013
K090300ace medical usMODIFICATION TO AUTOFUSERApril 30, 2009
K081905westmedACCUFLOW AND ACCUFLUX ELASTOMERIC INFUSION PUMPJuly 15, 2008
K071532advanced infusionALPHA INFUSION PUMP, MODEL A200, A450February 19, 2008
K072921symbios medical productsDISPOSABLE INFUSION PUMP KIT, GO PUMP RAPID RECOVERY SYSTEMNovember 26, 2007
K072053medical flow systemsSMARTBLOCK PAIN PUMPNovember 6, 2007
K071735symbios medical productsMODIFICATION TO DISPOSABLE INFUSION PUMP KITJuly 19, 2007
K071222baxter healthcareINFUSOR SV AND LV ELASTOMERIC INFUSION DEVICESMay 25, 2007
K063530i-flowON-Q, PAINBUSTER, C-BLOC, SELECT-A-FLOW, ONDEMAND, HOMEPUMP, ECLIPSE, C-SERIES, January 26, 2007
K061661advanced infusionSTA CATH ATTACHABLE INFISION CATHETER, MODEL STA20October 18, 2006
K062457baxter healthcare corporationINFUSOR SMALL VOLUME ELASTOMERIC INFUSION DEVICESSeptember 21, 2006
K061409precise medical productsSMARTINFUSER PAINPUMP, MODEL P49220 W/CATHETER SET; P49224N W/O CATHETER SETJune 16, 2006
K060258ace medical usAUTOFUSERMay 30, 2006
K060933apex medical technologiesSOLACE POST-OPERATIVE PAIN RELIEF INFUSION SYSTEMMay 9, 2006
K052999ethiconSEMPERFLO INFUSION SYSTEMMarch 22, 2006