Cleared Traditional

K133684 - ULTRABLOX (FDA 510(k) Clearance)

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K133684 · Bloxr Corporation · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2014
Decision
42d
Days
Class 2
Risk

K133684 is an FDA 510(k) clearance for the ULTRABLOX. 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 Cleared decision on January 13, 2014 after a review of 42 days - a notably fast clearance cycle.

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 establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Bloxr Corporation devices

Submission Details

510(k) Number K133684 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 2013
Decision Date January 13, 2014
Days to Decision 42 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
65d faster than avg
Panel avg: 107d · This submission: 42d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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.