PDKClass II

Cream For X-Ray Attenuation

21 CFR 892.6510 / Radiology

PDK is the FDA product code for Cream For X-Ray Attenuation, a class II device type, regulated under 21 CFR 892.6510. FDA's definition for this code 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 cream is intended to be used during medical procedures where its necessary for...". As of 2026-09-10, FDA records hold 2 510(k) clearances under this code, the most recent dated 2014-01-13, and no recalls.

Classification record

Product code: PDK
Device name: Cream For X-Ray Attenuation
FDA 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.
Regulation: 21 CFR 892.6510
Device class: Class II
Review panel: Radiology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: Yes
Ingested clearances: 2
Ingested recalls: 0

Clearances, product code PDK

By decision year

2 clearances under product code PDK with a decision year between 2013 and 2014, 2013 the highest year at 1.

Show the numbers

510(k) clearances under FDA product code PDK by decision year
Year	Clearances
2013	1
2014	1

Applicants with the most clearances

Product code PDK

Applicants holding the most 510(k) clearances under product code PDK
Applicant	Clearances
Bloxr Corporation	2

Companies listing this code with FDA

Companies whose registered establishments list this code

Recent clearances

Product code PDK

Recent recalls

Product code PDK

FDA records show no recalls under product code PDK.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)