Not Cleared Direct

DEN120022 - X-RAY ATTENUATING CREAM (FDA 510(k) Clearance)

Class II Radiology device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN120022 · Bloxr Corporation · Radiology device
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May 2013
Decision
183d
Days
Class 2
Risk

DEN120022 is an FDA 510(k) submission (not cleared) for the X-RAY ATTENUATING CREAM. Classified as Cream For X-ray Attenuation (product code PDK), Class II - Special Controls.

Submitted by Bloxr Corporation (Salt Lake City, US). The FDA issued a Not Cleared (DENG) decision on May 9, 2013 after a review of 183 days.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.6510 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. This submission did not achieve clearance, indicating the FDA determined the device lacked sufficient predicate equivalence under the Radiology review framework.

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Submission Details

510(k) Number DEN120022 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received November 07, 2012
Decision Date May 09, 2013
Days to Decision 183 days
Submission Type Direct
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
76d slower than avg
Panel avg: 107d · This submission: 183d
Pathway characteristics

Device Classification

Product Code PDK Cream For X-ray Attenuation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.6510
Definition The X-ray Attenuating Cream Is Intended For Use As A Radiation Shield. It Is Intended To Be Applied To The User's Hand Before Donning Gloves, Or It May Be Applied On A Gloved Hand, Followed By Donning A Second Glove. The X-ray Attenuating Cream Is Intended To Be Used During Medical Procedures Where Its Necessary For Hands To Be Exposed To Radiation To Offer Some Degree Of Protection From Radiation Exposure.
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.