Cleared Abbreviated

K062449 - EMPOWERMR INJECTOR SYSTEM, MODEL 9730

K062449 is an FDA 510(k) clearance for EMPOWERMR INJECTOR SYSTEM, manufactured by E-Z-Em, Inc.. The device is a Class 2 Cardiovascular device with product code IZQ cleared through the Abbreviated 510(k) pathway after a 234-day FDA review.

K062449 · E-Z-Em, Inc. · Cardiovascular device
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Apr 2007
Decision
234d
Days
Class 2
Risk

K062449 is an FDA 510(k) clearance for the EMPOWERMR INJECTOR SYSTEM, MODEL 9730. Classified as Injector, Contrast Medium, Automatic (product code IZQ), Class II - Special Controls.

Submitted by E-Z-Em, Inc. (Westbury, US). The FDA issued a Cleared decision on April 13, 2007 after a review of 234 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all E-Z-Em, Inc. devices

FDA 510(k) Submission Details - K062449

510(k) Number K062449 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 22, 2006
Decision Date April 13, 2007
Days to Decision 234 days
Submission Type Abbreviated
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
109d slower than avg
Panel avg: 125d · This submission: 234d
Pathway characteristics
Standards-based clearance path.

IZQ Device Classification - Class 2, Special Controls

Product Code IZQ Injector, Contrast Medium, Automatic
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 - IZQ Injector, Contrast Medium, Automatic

All 20
Devices cleared under the same product code (IZQ) and FDA review panel - the closest regulatory comparables to K062449.
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