Cleared Traditional

K102648 - ANT INFLATION DEVICE/ANT INFLATION DEVICE COMPACT PACK

K102648 is an FDA 510(k) clearance for ANT INFLATION DEVICE/ANT INFLATION DEVI..., manufactured by Shenzhen Ant Hi-Tech Industrial Co., Ltd.. The device is a Class 2 Cardiovascular device with product code MAV cleared through the Traditional 510(k) pathway after a 290-day FDA review.

K102648 · Shenzhen Ant Hi-Tech Industrial Co., Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
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Jul 2011
Decision
290d
Days
Class 2
Risk

K102648 is an FDA 510(k) clearance for the ANT INFLATION DEVICE/ANT INFLATION DEVICE COMPACT PACK. Classified as Syringe, Balloon Inflation (product code MAV), Class II - Special Controls.

Submitted by Shenzhen Ant Hi-Tech Industrial Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on July 1, 2011 after a review of 290 days - an extended review cycle.

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. Standard predicate reliance. 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 Shenzhen Ant Hi-Tech Industrial Co., Ltd. devices

FDA 510(k) Submission Details - K102648

510(k) Number K102648 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 2010
Decision Date July 01, 2011
Days to Decision 290 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
165d slower than avg
Panel avg: 125d · This submission: 290d
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 46
Devices cleared under the same product code (MAV) and FDA review panel - the closest regulatory comparables to K102648.
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VANGUARD REPROCESSED INFLATION DEVICES
K012480 · Vanguard Medical Concepts, Inc. · Jan 2002