510(k) Report

FDA applicant

Bloxr Corporation

Salt Lake City, UT3 decisions2011–20140 recalls

FDA records 3 decisions for Bloxr Corporation (Salt Lake City, UT) from 2011 to 2014: 2 510(k) clearances and 1 De Novo grant. Most are in product codes PDK (Cream For X-Ray Attenuation) and KPY (Shield, Protective, Personnel). Its devices cite 1 predicate, 1 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, radiology panel, where it files most

How often FDA has decided Bloxr Corporation’s devices, and how often a recall has named them.

FDA decisions per year

1in 2014

2011: 12013: 12014: 1
2011high 1 (2011) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2011.

FIG. 1 — Bloxr Corporation by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • PDKCream For X-Ray Attenuation2decisions
  • KPYShield, Protective, Personnel1decision

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • DEN120022X-Ray Attenuating CreamBloxr Corporation · 20131cites it

What has FDA decided for it lately?

  • K133684UltrabloxBloxr Corporation · 2014
  • DEN120022X-Ray Attenuating CreamBloxr Corporation · 2013
  • K110900Disposable Thyroid CollarBloxr Corporation · 2011

All 3 as Bloxr Corporation →