Cleared Traditional

K072053 - SMARTBLOCK PAIN PUMP

K072053 is an FDA 510(k) clearance for SMARTBLOCK PAIN PUMP, manufactured by Medical Flow Systems, Ltd.. The device is a Class 2 General Hospital device with product code MEB cleared through the Traditional 510(k) pathway after a 103-day FDA review.

K072053 · Medical Flow Systems, Ltd. · General Hospital
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Nov 2007
Decision
103d
Days
Class 2
Risk

K072053 is an FDA 510(k) clearance for the SMARTBLOCK PAIN PUMP. Classified as Pump, Infusion, Elastomeric (product code MEB), Class II - Special Controls.

Submitted by Medical Flow Systems, Ltd. (Leawood, US). The FDA issued a Cleared decision on November 6, 2007 after a review of 103 days - within the typical 510(k) review window.

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 Medical Flow Systems, Ltd. devices

FDA 510(k) Submission Details - K072053

510(k) Number K072053 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 2007
Decision Date November 06, 2007
Days to Decision 103 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 129d · This submission: 103d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 49
Devices cleared under the same product code (MEB) and FDA review panel - the closest regulatory comparables to K072053.
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
SMARTez elastomeric infusion pump
K151650 · Epic Medical Pte. , Ltd. · Apr 2016
INFUSOR SV AND LV ELASTOMERIC INFUSION DEVICES
K071222 · Baxter Healthcare Corp · May 2007
ON-Q, PAINBUSTER, C-BLOC, SELECT-A-FLOW, ONDEMAND, HOMEPUMP, ECLIPSE, C-SERIES, ONE-STEP KVO, EASYPUMP
K063530 · I-Flow Corp. · Jan 2007
INFUSOR SMALL VOLUME ELASTOMERIC INFUSION DEVICES
K062457 · Baxter Healthcare Corporation · Sep 2006