Cleared Traditional

K140943 - MASTRO PLUS BALLOON IN-DEFLATION DEVICE

K140943 is an FDA 510(k) clearance for MASTRO PLUS BALLOON IN-DEFLATION DEVICE, manufactured by Beijing Demax Medical Technology Co.,Ltd. The device is a Class 2 Cardiovascular device with product code MAV cleared through the Traditional 510(k) pathway after a 325-day FDA review.

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.

View all Beijing Demax Medical Technology Co.,Ltd devices

FDA 510(k) Submission Details - K140943

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.

MAV Device Classification - Class 2, Special Controls

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.

Regulatory Peers - MAV Syringe, Balloon Inflation

All 33
Devices cleared under the same product code (MAV) and FDA review panel - the closest regulatory comparables to K140943.
Everest 20 Disposable Inflation Device, Everest 20 Survival Kit, Everest 30 Disposable Inflation Device, Everest 30 Survival Kit
K153038 · Medtronic, Inc. · Apr 2016
basixTOUCH40 Inflation Syringe
K153672 · Merit Medical Systems, Inc. · Jan 2016
Fluent Inflation Device
K152387 · Vascular Solutions, Inc. · Dec 2015
Presto Inflation Device
K143522 · C.R. Bard, Inc. · Jan 2015
ENCORE 26 ADVANTAGE KIT
K140745 · Boston Scientific Corp · Apr 2014
BASIXTOUCH
K130566 · Merit Medical Systems, Inc. · Jun 2013