FDA product code PDK: Cream For X-Ray Attenuation
PDK is the FDA product code for cream for x-ray attenuation. It is a Class II device, regulated under 21 CFR 892.6510 and reviewed by the Radiology panel. FDA has cleared 1 510(k) submission under PDK. The average 510(k) review took 42 days (median 42). 1 De Novo request was granted under it.
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.
Classification
| Field | Value |
|---|---|
| Device name | Cream For X-Ray Attenuation |
| Device class | Class II |
| Regulation | 21 CFR 892.6510 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every PDK clearance
Top PDK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Bloxr Corporation | 1 | 2014-01-13 |
Most recent PDK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K133684 | Bloxr Corporation | ULTRABLOX | 2014-01-13 | 42 |
Recalls for PDK devices
openFDA lists no recalls for product code PDK.
Frequently asked questions
What is FDA product code PDK?
PDK is the FDA product code for cream for x-ray attenuation. It is a Class II device, regulated under 21 CFR 892.6510 and reviewed by the Radiology panel.
What device class is PDK?
Class II, regulation 21 CFR 892.6510. Typical premarket route: 510(k).
How long does a 510(k) take for product code PDK?
Across 1 cleared submissions the average was 42 days from receipt to decision (median 42).
Which companies have the most PDK clearances?
Bloxr Corporation (1).
Next steps
- Run an FDA pathway report with predicate devices for product code PDK
- Run a recall and safety report across every PDK manufacturer
- Watch product code PDK for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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