510(k) Report

FDA applicant

Shantou Huihengqi Electronic Technology Co., Ltd.

Shantou, CN1 decision2022–20220 recalls

FDA records 1 decision for Shantou Huihengqi Electronic Technology Co., Ltd. (Shantou, CN) in 2022: 1 510(k) clearance. All are in product code HGX (Pump, Breast, Powered). 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, obstetrics and gynecology panel, where it files most

How often FDA has decided Shantou Huihengqi Electronic Technology Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2022: 1
2022high 1 (2022) · low 0 (2023)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2022.

FIG. 1 — Shantou Huihengqi Electronic Technology Co., Ltd. by year, 2022–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • HGXPump, Breast, Powered1decision

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 3 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.

  • K211024Electric Breast PumpShantou Huihengqi Electronic Technology Co., Ltd. · 20223cite it

What has FDA decided for it lately?

  • K211024Electric Breast PumpShantou Huihengqi Electronic Technology Co., Ltd. · 2022

The one decision as Shantou Huihengqi Electronic Technology Co., Ltd. →

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 11Shantou Institute of Ultrasonic Instruments Co., Ltd.… 8Shantou Wealy Medical Instrument Co.,Ltd 6Shantou Institute of Ultrasonic Instruments (Siui 5Shantou Institute of Ultrasonic Instruments Co., Ltd. 3Shantou Xinghe Electrical Apparatuses Co., Ltd. 2Shantou T&K Medical Equipment Factory Co.,Ltd 1