510(k) Report

FDA applicant

Haynes Radiation Ltd., Inc.

Alameda, CA2 decisions1983–19890 recalls

FDA records 2 decisions for Haynes Radiation Ltd., Inc. (Alameda, CA) from 1983 to 1989: 2 510(k) clearances. All are in product code KPQ (System, Simulation, Radiation Therapy). 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 Haynes Radiation Ltd., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Haynes Radiation Ltd., Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Haynes Radiation Ltd., 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?

  • KPQSystem, Simulation, Radiation Therapy2decisions

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.

  • K834281Rad II SimulatorHaynes Radiation Ltd., Inc. · 19831cites it

What has FDA decided for it lately?

  • K885081Simrite Verification and Simulation SystemHaynes Radiation Ltd., Inc. · 1989
  • K834281Rad II SimulatorHaynes Radiation Ltd., Inc. · 1983

All 2 as Haynes Radiation Ltd., Inc. →