Cleared Traditional

K151650 - SMARTez elastomeric infusion pump

K151650 is an FDA 510(k) clearance for SMARTez elastomeric infusion pump, manufactured by Epic Medical Pte. , Ltd.. The device is a Class 2 General Hospital device with product code MEB cleared through the Traditional 510(k) pathway after a 291-day FDA review.

K151650 · Epic Medical Pte. , Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2016
Decision
291d
Days
Class 2
Risk

K151650 is an FDA 510(k) clearance for the SMARTez elastomeric infusion pump. 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 April 4, 2016 after a review of 291 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5725 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Epic Medical Pte. , Ltd. devices

FDA 510(k) Submission Details - K151650

510(k) Number K151650 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 2015
Decision Date April 04, 2016
Days to Decision 291 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
162d slower than avg
Panel avg: 129d · This submission: 291d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Third Party Review Group, LLC
DAVE YUNGVIRT

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - MEB Pump, Infusion, Elastomeric

All 59
Devices cleared under the same product code (MEB) and FDA review panel - the closest regulatory comparables to K151650.
InfuLife
K240624 · First Medical Source, LLC · Nov 2024
SMARTeZ™ Elastomeric Infusion Pump (498111, 498121, 498131, 498141)
K242152 · Epic Medical Pte. , Ltd. · Oct 2024
ON-Q* Pump with Bolus
K181360 · Halyard Health · Mar 2019
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
INFUSOR SV AND LV ELASTOMERIC INFUSION DEVICES
K071222 · Baxter Healthcare Corp · May 2007

FDA 510(k) Resources - General Hospital

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.