FDA.reportPublic FDA data

510(k) K242152

Device
SMARTeZ? Elastomeric Infusion Pump (498111, 498121, 498131, 498141)
Applicant
Epic Medical Pte. , Ltd.
510(k) number
K242152
Product code
MEB
Decision
Substantially Equivalent (SESE)
Decision date
2024-10-07
Date received
2024-07-23
Regulation
880.5725
Classification name
Pump, Infusion, Elastomeric
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Freddie Lee
Address
105 Cecil St. #20-04 The Octagon Singapore SG 069534 069534

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MEB#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K250234SMARTeZ™ Elastomeric Infusion Pump (RS series)Epic Medical Pte. , Ltd.2026-04-24
K240624InfuLifeFirst Medical Source, LLC2024-11-05
K181360ON-Q* Pump with BolusHalyard Health2019-03-22
K151650SMARTez elastomeric infusion pumpEpic Medical Pte. , Ltd.2016-04-04
K131249ON-Q PAINBUSTER, ON-Q C-BLOC, HOMEPUMP ECLIPSE, HOMEPUMP C-SERIESI-Flow, LLC2014-02-03
K131247MULTIBOLUS II DISPOSABLE PAIN MANAGEMENT SYSTEMMfs - Medical Flow Systems, Ltd.2013-08-14
K090300MODIFICATION TO AUTOFUSERAce Medical Us, LLC2009-04-30
K081905ACCUFLOW AND ACCUFLUX ELASTOMERIC INFUSION PUMPWestmed, Inc.2008-07-15
K071532ALPHA INFUSION PUMP, MODEL A200, A450Advanced Infusion, Inc.2008-02-19
K072921DISPOSABLE INFUSION PUMP KIT, GO PUMP RAPID RECOVERY SYSTEMSymbios Medical Products, LLC2007-11-26
K072053SMARTBLOCK PAIN PUMPMedical Flow Systems, Ltd.2007-11-06
K071735MODIFICATION TO DISPOSABLE INFUSION PUMP KITSymbios Medical Products, LLC2007-07-19
K071222INFUSOR SV AND LV ELASTOMERIC INFUSION DEVICESBaxter Healthcare Corp2007-05-25
K063530ON-Q, PAINBUSTER, C-BLOC, SELECT-A-FLOW, ONDEMAND, HOMEPUMP, ECLIPSE, C-SERIES, ONE-STEP KVO, EASYPUMPI-Flow Corp.2007-01-26
K061661STA CATH ATTACHABLE INFISION CATHETER, MODEL STA20Advanced Infusion, Inc.2006-10-18