Cleared Special

K242152 - SMARTeZ™ Elastomeric Infusion Pump (498111, 498121, 498131, 498141)

K242152 is an FDA 510(k) clearance for SMARTeZ Elastomeric Infusion Pump (498111, manufactured by Epic Medical Pte. , Ltd.. The device is a Class 2 General Hospital device with product code MEB cleared through the Special 510(k) pathway after a 76-day FDA review.

K242152 · Epic Medical Pte. , Ltd. · General Hospital
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Optimized for regulatory review, auditing and printing
Oct 2024
Decision
76d
Days
Class 2
Risk

K242152 is an FDA 510(k) clearance for the SMARTeZ™ Elastomeric Infusion Pump (498111, 498121, 498131, 498141). Classified as Pump, Infusion, Elastomeric (product code MEB), Class II - Special Controls.

Submitted by Epic Medical Pte. , Ltd. (Singapore, SG). The FDA issued a Cleared decision on October 7, 2024 after a review of 76 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5725 - the FDA general hospital device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Epic Medical Pte. , Ltd. devices

FDA 510(k) Submission Details - K242152

510(k) Number K242152 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 129d · This submission: 76d
Pathway characteristics
Modification to existing cleared device.

MEB Device Classification - Class 2, Special Controls

Product Code MEB Pump, Infusion, Elastomeric
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5725
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - MEB Pump, Infusion, Elastomeric

All 58
Devices cleared under the same product code (MEB) and FDA review panel - the closest regulatory comparables to K242152.
SMARTeZ™ Elastomeric Infusion Pump (RS series)
K250234 · Epic Medical Pte. , Ltd. · Apr 2026
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