510(k) Report

FDA applicant

Burkhart Roentgen Intl., Inc.

Pinellas Park, FL3 decisions1992–19920 recalls

FDA records 3 decisions for Burkhart Roentgen Intl., Inc. (Pinellas Park, FL) in 1992: 3 510(k) clearances. Most are in product codes IWZ (Film, Radiographic) and IWP (Radiographic Protective Glove). 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 Burkhart Roentgen Intl., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Burkhart Roentgen Intl., Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Burkhart Roentgen Intl., Inc. 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?

  • IWZFilm, Radiographic1decision
  • IWPRadiographic Protective Glove1decision
  • IWSShield, Eye, Radiological1decision

What has FDA decided for it lately?

  • K920539Orwo X-Ray FilmBurkhart Roentgen Intl., Inc. · 1992
  • K920538Protective Radiografic GloveBurkhart Roentgen Intl., Inc. · 1992
  • K920540Radiological Protective Eye ShieldBurkhart Roentgen Intl., Inc. · 1992

All 3 as Burkhart Roentgen Intl., Inc. →