510(k) Report

FDA applicant

Tianjin Medis International Trade Co., Ltd.

Hexi District, Tianjin, CN1 decision2006–20060 recalls

FDA records 1 decision for Tianjin Medis International Trade Co., Ltd. (Hexi District, Tianjin, CN) in 2006: 1 510(k) clearance. All are in product code FPA (Set, Administration, Intravascular). 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, general hospital panel, where it files most

How often FDA has decided Tianjin Medis International Trade Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Tianjin Medis International Trade Co., Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Tianjin Medis International Trade Co., Ltd. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Tianjin Medis International Trade Co.…’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • FPASet, Administration, Intravascular1decision

Who builds on its devices?

Later devices cite its devices 2 times; 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.

  • K060082Tianjin Medis Disposable Infusion SetTianjin Medis International Trade Co., Ltd. · 20062cite it

What has FDA decided for it lately?

  • K060082Tianjin Medis Disposable Infusion SetTianjin Medis International Trade Co., Ltd. · 2006

The one decision as Tianjin Medis International Trade Co., Ltd. →