510(k) Report

FDA applicant

Beekley Corp.

Bristol, CT2 decisions2002–20081 recall

FDA records 2 decisions for Beekley Corp. (Bristol, CT) from 2002 to 2008: 2 510(k) clearances. All are in product code IZH (System, X-Ray, Mammographic). Its devices cite 1 predicate, 0 of them its own earlier devices. 1 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 Beekley Corp.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2008

2008: 1
2007high 1 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2012

2012: 1
2007high 1 (2012) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Beekley Corp. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • IZHSystem, X-Ray, Mammographic2decisions

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K073262BELLABeekley Corp. · 20081cites it

What has FDA decided for it lately?

  • K073262BELLABeekley Corp. · 20081 recall
  • K020624Breast BolsterBeekley Corp. · 2002

All 2 as Beekley Corp. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K073262Bella Blanket Protective Coverlet, for Mammography, 18cm x 25cm or 24cm x 30cm, Product…Jul 2, 2012Class II