510(k) · Cleared
ClearedUltrablox
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bloxr Corporation · PDK Cream For X-Ray Attenuation
Cleared on Jan 13, 2014 as substantially equivalent to DEN120022 (Bloxr Corporation, 2013) after a 42-day review. Its family tree reaches back 1 generation to 2013.
- Decided
- Jan 13, 2014
- Review
- 42 days
- Class
- Class II
- Product code
- PDK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN120022 (2013). No later device cites it as a predicate yet.
- Root · 1 generation backDEN120022 X-Ray Attenuating CreamBloxr Corporation · 2013
- This deviceK133684 UltrabloxBloxr Corporation · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN120022 | X-Ray Attenuating Cream | Bloxr Corporation | 2013 | — |
| 0 (this device) | K133684 | Ultrablox | Bloxr Corporation | 2014 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in PDK? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | DEN120022 | X-Ray Attenuating Cream Our reading of the summary gave K123422, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN120022, X-Ray Attenuating Cream (Bloxr Corporation), granted May 9, 2013; older De Novo requests were first filed under a 510(k) number, so this links to the grant. | 2013 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
How does its category compare?
All PDK devicesPDK Cream For X-Ray Attenuation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · PDK
1in 2014
2026 to Oct 25, outlined.
Median 510(k) review, days · PDK
Too few PDK 510(k)s in any year since 2007 to give a median.
Recalls per year · PDK
No recall names PDK since 2007.
Adverse event reports per year · PDK
No MAUDE report names PDK since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The UltraBLOX 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 glove on the hand, followed by donning a second glove. The UIb~aBLOX X-ray Attenuating Cream is intended to be used during medical procedures where hands are necessarily exposed to radiation to offer some degree of protection from radiation exposure in the diagnostic imaging range of up to 130 kVp. This may include surgical procedures that require the use of fluoroscopy or radiography or other procedures.
NOTE: For use with natural rubber latex and latex-free poly-isoprene Surgeon's Gloves only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133684 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133684: Ultrablox.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133684
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026