510(k) Report

FDA applicant

Our United Corporation

Xi'An, CN3 decisions2020–20210 recalls

FDA records 3 decisions for Our United Corporation (Xi'An, CN) from 2020 to 2021: 3 510(k) clearances. Most are in product codes IYE (Accelerator, Linear, Medical) and IWB (System, Radiation Therapy, Radionuclide). Its devices cite 3 predicates, 1 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 Our United Corporation’s devices, and how often a recall has named them.

FDA decisions per year

2in 2021

2020: 12021: 2
2020high 2 (2021) · low 0 (2022)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2020.

FIG. 1 — Our United Corporation by year, 2020–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • IYEAccelerator, Linear, Medical2decisions
  • IWBSystem, Radiation Therapy, Radionuclide1decision

Whose devices does it build on?

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

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K193207TaiChiAOur United Corporation · 20201cites it

What has FDA decided for it lately?

  • K210921TaiChiBOur United Corporation · 2021
  • K203250TaiChiCOur United Corporation · 2021
  • K193207TaiChiAOur United Corporation · 2020

All 3 as Our United Corporation →