510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K133684Substantially Equivalent

Ultrablox

Bloxr Corporation, Salt Lake City UT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K133684 is the FDA 510(k) clearance record for ULTRABLOX, a class II device, cleared for Bloxr Corporation on under FDA product code PDK (Cream For X-Ray Attenuation). FDA's definition for product code PDK reads: "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...". FDA records list 3 510(k) clearances for Bloxr Corporation, from to . As of , FDA records show no recalls naming K133684.

Clearance record

Decision date
Received
(42 days to decision)
Product code
PDK Cream For X-Ray Attenuation
Regulation
21 CFR 892.6510
Device class
Class II
Review panel
Radiology
Applicant
Bloxr Corporation 960 Levoy Dr., Salt Lake City UT
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PDK

Trailing 12 months

FDA records hold no clearances under product code PDK in the trailing twelve months.

FDA records show no clearances under product code PDK in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PDK, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260