510(k) Report

FDA applicant

Macan Engineering Co.

Chicago, IL2 decisions2005–20051 recall

FDA records 2 decisions for Macan Engineering Co. (Chicago, IL) in 2005: 2 510(k) clearances. All are in product code EKZ (Unit, Electrosurgical, And Accessories, Dental). Its devices cite 3 predicates, 1 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, dental panel, where it files most

How often FDA has decided Macan Engineering Co.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Macan Engineering Co. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Macan Engineering Co. 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?

  • EKZUnit, Electrosurgical, And Accessories, Dental2decisions

Whose devices does it build on?

Its devices cite 3 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 1 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.

  • K050735MC6AMacan Engineering Co. · 20052cite it

What has FDA decided for it lately?

  • K052622Macan Model MC-4A Dental Electrosurgical UnitMacan Engineering Co. · 20051 recall
  • K050735MC6AMacan Engineering Co. · 2005

All 2 as Macan Engineering Co. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K052622Macan Model MC-4A Dental Electrosurgical Unit; Macan Engineering and Manufacturing Co.…Apr 5, 2006