Cleared Traditional

K122152 - OXTI INFLATION DEVICE

K122152 is an FDA 510(k) clearance for OXTI INFLATION DEVICE, manufactured by Oxti Corporation. The device is a Class 2 Cardiovascular device with product code MAV cleared through the Traditional 510(k) pathway after a 147-day FDA review.

K122152 · Oxti Corporation · Cardiovascular device
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Dec 2012
Decision
147d
Days
Class 2
Risk

K122152 is an FDA 510(k) clearance for the OXTI INFLATION DEVICE. Classified as Syringe, Balloon Inflation (product code MAV), Class II - Special Controls.

Submitted by Oxti Corporation (Houston, US). The FDA issued a Cleared decision on December 14, 2012 after a review of 147 days - within the typical 510(k) review window.

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 Oxti Corporation devices

FDA 510(k) Submission Details - K122152

510(k) Number K122152 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 2012
Decision Date December 14, 2012
Days to Decision 147 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
22d slower than avg
Panel avg: 125d · This submission: 147d
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 39
Devices cleared under the same product code (MAV) and FDA review panel - the closest regulatory comparables to K122152.
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
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