Cleared Traditional

K151650 - SMARTez elastomeric infusion pump (FDA 510(k) Clearance)

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K151650 · Epic Medical Pte. , Ltd. · General Hospital
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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

Submission Details

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
Regulatory Context
Review time vs. panel average
163d slower than avg
Panel avg: 128d · This submission: 291d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

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 87
Devices cleared under the same product code (MEB) and FDA review panel - the closest regulatory comparables to K151650.
SMARTeZ™ Elastomeric Infusion Pump (RS series)
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ON-Q* Pump with Bolus
K181360 · Halyard Health · Mar 2019