510(k) Report

FDA applicant

Oldelft Corp. of America

Fairfax, VA9 decisions1989–19980 recalls

FDA records 9 decisions for Oldelft Corp. of America (Fairfax, VA) from 1989 to 1998: 9 510(k) clearances. Most are in product codes KPQ (System, Simulation, Radiation Therapy) and KPR (System, X-Ray, Stationary). Its devices cite 3 predicates, 2 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 Oldelft Corp. of America’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Oldelft Corp. of America since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Oldelft Corp. of America 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?

  • KPQSystem, Simulation, Radiation Therapy2decisions
  • KPRSystem, X-Ray, Stationary2decisions
  • KQADevice, Beam Limiting, X-Ray, Therapeutic1decision
  • JADSystem, Therapeutic, X-Ray1decision
  • IZOGenerator, High-Voltage, X-Ray, Diagnostic1decision
  • JAKSystem, X-Ray, Tomography, Computed1decision

Also: IZG (1).

Whose devices does it build on?

Its devices cite 3 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 7 times; 2 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.

  • K946128Simulix-HPOldelft Corp. of America · 19952cite it
  • K980296Oldelft DigidelcaOldelft Corp. of America · 19981cites it
  • K912466Oldelft Simulix-MCOldelft Corp. of America · 19911cites it
  • K932848Simulix-MC CT ExtensionOldelft Corp. of America · 19941cites it
  • K892659ElectrodelcaOldelft Corp. of America · 19891cites it
  • K973219Amber DUOldelft Corp. of America · 19971cites it

What has FDA decided for it lately?

  • K980296Oldelft DigidelcaOldelft Corp. of America · 1998
  • K973219Amber DUOldelft Corp. of America · 1997
  • K946128Simulix-HPOldelft Corp. of America · 1995
  • K950037N 800 HFOldelft Corp. of America · 1995
  • K932848Simulix-MC CT ExtensionOldelft Corp. of America · 1994
  • K923584Therapax DXT 300 Series 3Oldelft Corp. of America · 1993
  • K914784Papillion ProctoscopeOldelft Corp. of America · 1992
  • K912466Oldelft Simulix-MCOldelft Corp. of America · 1991

All 9 as Oldelft Corp. of America →