Cleared Special

K142294 - FlexiMarc Marker

K142294 is an FDA 510(k) clearance for FlexiMarc Marker, manufactured by Cortex Manufacturing, Inc.. The device is a Class 2 Radiology device with product code IYE cleared through the Special 510(k) pathway after a 220-day FDA review.

K142294 · Cortex Manufacturing, Inc. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2015
Decision
220d
Days
Class 2
Risk

K142294 is an FDA 510(k) clearance for the FlexiMarc Marker. Classified as Accelerator, Linear, Medical (product code IYE), Class II - Special Controls.

Submitted by Cortex Manufacturing, Inc. (Lake Stevens, US). The FDA issued a Cleared decision on March 26, 2015 after a review of 220 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5050 - the FDA radiology and imaging software oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K142294

510(k) Number K142294 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 2014
Decision Date March 26, 2015
Days to Decision 220 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
113d slower than avg
Panel avg: 107d · This submission: 220d
Pathway characteristics
Modification to existing cleared device.

IYE Device Classification - Class 2, Special Controls

Product Code IYE Accelerator, Linear, Medical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5050
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 Radiology devices follow this clearance model.

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All 679
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