FDA applicant

Shantou T&K Medical Equipment Factory Co.,Ltd

Shantou, CN1 decision2021–20210 recalls

FDA records 1 decision for Shantou T&K Medical Equipment Factory Co.,Ltd (Shantou, CN) in 2021: 1 510(k) clearance. All are in product code FXX (Mask, Surgical). 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, general and plastic surgery panel, where it files most

How often FDA has decided Shantou T&K Medical Equipment Factory Co.,Ltd’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2021high 1 (2021) · low 0 (2022)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2021.

FIG. 1 — Shantou T&K Medical Equipment Factory Co.,Ltd by year, 2021–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Shantou T&K Medical Equipment Factory…’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Other applicant names beginning “Shantou”

FDA records each applicant name separately; these may or may not be the same firm.

Shantou Institute of Ultrasonic Instuments 11 Shantou Institute of Ultrasonic Instruments Co., Ltd.… 8 Shantou Wealy Medical Instrument Co.,Ltd 6 Shantou Institute of Ultrasonic Instruments (Siui 5 Shantou Institute of Ultrasonic Instruments Co., Ltd. 3 Shantou Xinghe Electrical Apparatuses Co., Ltd. 2 Shantou Huihengqi Electronic Technology Co., Ltd. 1

Shantou T&K Medical Equipment Factory Co.,Ltd

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Shantou”