Cleared Traditional

K102648 - ANT INFLATION DEVICE/ANT INFLATION DEVI...

K102648 is the FDA 510(k) clearance for ANT INFLATION DEVICE/ANT INFLATION DEVI... by Shenzhen Ant Hi-Tech Industrial Co., Ltd.. It is a Class 2 Cardiovascular device (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)
Optimized for regulatory review, auditing and printing
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

Submission Details

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.

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.

Regulatory Peers - MAV Syringe, Balloon Inflation

All 29
Devices cleared under the same product code (MAV) and FDA review panel - the closest regulatory comparables to K102648.
BASIXTOUCH
K130566 · Merit Medical Systems, Inc. · Jun 2013
ENCORE 26 ADVANTAGE KIT
K123214 · Boston Scientific Corp · Nov 2012
ENCORE 26 ADVANTAGE KIT
K120694 · Boston Scientific Corp · Apr 2012
VICEROY INFLATION DEVICE
K040138 · Merit Medical Systems, Inc. · Feb 2004
INTELLISYSTEM II COLOR MONITOR
K993341 · Merit Medical Systems, Inc. · Oct 1999
INDEFLATOR PLUS 30/PLUS 30 PRIORITY PACK9WITH THE.096 OR.115 ROTATING HEMOSTATIC VALVE)
K962495 · Advanced Cardiovascular Systems, Inc. · Sep 1996