510(k) Report

FDA applicant

Shantou Xinghe Electrical Apparatuses Co., Ltd.

Shantou, Guangdong, CN2 decisions2014–20150 recalls

FDA records 2 decisions for Shantou Xinghe Electrical Apparatuses Co., Ltd. (Shantou, Guangdong, CN) from 2014 to 2015: 2 510(k) clearances. All are in product code HGX (Pump, Breast, Powered). Its devices cite 2 predicates, 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 Xinghe Electrical Apparatuses Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2014: 12015: 1
2014high 1 (2014) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

FIG. 1 — Shantou Xinghe Electrical Apparatuses Co., Ltd. by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Shantou Xinghe Electrical Apparatuses…’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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Which product codes does it file in?

  • HGXPump, Breast, Powered2decisions

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K143585Electric Breast PumpShantou Xinghe Electrical Apparatuses Co., Ltd. · 20151cites it

What has FDA decided for it lately?

  • K143585Electric Breast PumpShantou Xinghe Electrical Apparatuses Co., Ltd. · 2015
  • K132882Electric Breast PumpShantou Xinghe Electrical Apparatuses Co., Ltd. · 2014

All 2 as Shantou Xinghe Electrical Apparatuses 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 Huihengqi Electronic Technology Co., Ltd. 1Shantou T&K Medical Equipment Factory Co.,Ltd 1