510(k) Report

FDA applicant

Tianjin Medis Medical Device Co., Ltd.

Tainjin, CN3 decisions2017–20190 recalls

FDA records 3 decisions for Tianjin Medis Medical Device Co., Ltd. (Tainjin, CN) from 2017 to 2019: 3 510(k) clearances. Most are in product codes BTR (Tube, Tracheal (W/Wo Connector)) and BSK (Cuff, Tracheal Tube, Inflatable). Its devices cite 8 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, anesthesiology panel, where it files most

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

FDA decisions per year

2in 2019

2017: 12019: 2
2017high 2 (2019) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2017.

FIG. 1 — Tianjin Medis Medical Device Co., Ltd. by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Tianjin Medis Medical Device Co., Ltd.’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?

  • BTRTube, Tracheal (W/Wo Connector)2decisions
  • BSKCuff, Tracheal Tube, Inflatable1decision

Whose devices does it build on?

Its devices cite 8 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.

  • K160694Disposable Endotracheal tube, sterile, AccuCuffTianjin Medis Medical Device Co., Ltd. · 20171cites it

What has FDA decided for it lately?

  • K190274Endotracheal TubeTianjin Medis Medical Device Co., Ltd. · 2019
  • K182548Accucuff Cuff Pressure IndicatorTianjin Medis Medical Device Co., Ltd. · 2019
  • K160694Disposable Endotracheal tube, sterile, AccuCuffTianjin Medis Medical Device Co., Ltd. · 2017

All 3 as Tianjin Medis Medical Device Co., Ltd. →