Cleared Special

SMARTeZ? Elastomeric Infusion Pump (498111, 498121, 498131, 498141)

K242152 · Epic Medical Pte. , Ltd. · General Hospital
Oct 2024
Decision
76d
Days
Class 2
Risk

About This 510(k) Submission

K242152 is an FDA 510(k) clearance for the SMARTeZ? Elastomeric Infusion Pump (498111, 498121, 498131, 498141), a Pump, Infusion, Elastomeric (Class II — Special Controls, product code MEB), submitted by Epic Medical Pte. , Ltd. (Singapore, SG). The FDA issued a Cleared decision on October 7, 2024, 76 days after receiving the submission on July 23, 2024. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number K242152 FDA.gov
FDA Decision Cleared SESE
Date Received July 23, 2024
Decision Date October 07, 2024
Days to Decision 76 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code MEB — Pump, Infusion, Elastomeric
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5725

Similar Devices — MEB Pump, Infusion, Elastomeric

All 86
InfuLife
K240624 · First Medical Source, LLC · Nov 2024
ON-Q* Pump with Bolus
K181360 · Halyard Health · Mar 2019
SMARTez elastomeric infusion pump
K151650 · Epic Medical Pte. , Ltd. · Apr 2016
ON-Q PAINBUSTER, ON-Q C-BLOC, HOMEPUMP ECLIPSE, HOMEPUMP C-SERIES
K131249 · I-Flow, LLC · Feb 2014
MULTIBOLUS II DISPOSABLE PAIN MANAGEMENT SYSTEM
K131247 · Mfs - Medical Flow Systems, Ltd. · Aug 2013
MODIFICATION TO AUTOFUSER
K090300 · Ace Medical Us, LLC · Apr 2009