510(k) Report

FDA applicant

Shandong Int Medical Instruments Co., Ltd.

Rizhao, CN2 decisions2024–20250 recalls

FDA records 2 decisions for Shandong Int Medical Instruments Co., Ltd. (Rizhao, CN) from 2024 to 2025: 2 510(k) clearances. All are in product code DXT (Injector And Syringe, Angiographic). Its devices cite 1 predicate, 0 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, cardiovascular panel, where it files most

How often FDA has decided Shandong Int Medical Instruments Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2024: 12025: 1
2024high 1 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2024.

FIG. 1 — Shandong Int Medical Instruments Co., Ltd. by year, 2024–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • DXTInjector And Syringe, Angiographic2decisions

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

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.

  • K244038High Pressure TubingShandong Int Medical Instruments Co., Ltd. · 20251cites it

What has FDA decided for it lately?

  • K244038High Pressure TubingShandong Int Medical Instruments Co., Ltd. · 2025
  • K242143Angiography InjectorShandong Int Medical Instruments Co., Ltd. · 2024

All 2 as Shandong Int Medical Instruments Co., Ltd. →