Cleared Traditional

K140943 - MASTRO PLUS BALLOON IN-DEFLATION DEVICE (FDA 510(k) Clearance)

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

K140943 · Beijing Demax Medical Technology Co.,Ltd · Cardiovascular device
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Mar 2015
Decision
325d
Days
Class 2
Risk

K140943 is an FDA 510(k) clearance for the MASTRO PLUS BALLOON IN-DEFLATION DEVICE. Classified as Syringe, Balloon Inflation (product code MAV), Class II - Special Controls.

Submitted by Beijing Demax Medical Technology Co.,Ltd (Guangzhou, CN). The FDA issued a Cleared decision on March 5, 2015 after a review of 325 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1650 - the FDA cardiovascular device oversight 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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K140943 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 2014
Decision Date March 05, 2015
Days to Decision 325 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
200d slower than avg
Panel avg: 125d · This submission: 325d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MAV Syringe, Balloon Inflation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1650
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 Cardiovascular devices follow this clearance model.