510(k) Report

FDA applicant

Gentec (Shanghai) Corporation

Songjiang District, CN1 decision2015–20150 recalls

FDA records 1 decision for Gentec (Shanghai) Corporation (Songjiang District, CN) in 2015: 1 510(k) clearance. All are in product code BZR (Mixer, Breathing Gases, Anesthesia Inhalation). 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, anesthesiology panel, where it files most

How often FDA has decided Gentec (Shanghai) Corporation’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2015: 1
2015high 1 (2015) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2015.

FIG. 1 — Gentec (Shanghai) Corporation by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • BZRMixer, Breathing Gases, Anesthesia Inhalation1decision

Whose devices does it build on?

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

What has FDA decided for it lately?

  • K142291GMX Series Medical Air/Oxygen BlenderGentec (Shanghai) Corporation · 2015

The one decision as Gentec (Shanghai) Corporation →