510(k) Report

FDA applicant

Ningbo Youhe Electrical Appliance Technology Co., Ltd.

Cixi, CN4 decisions2017–20250 recalls

FDA records 4 decisions for Ningbo Youhe Electrical Appliance Technology Co., Ltd. (Cixi, CN) from 2017 to 2025: 4 510(k) clearances. All are in product code HGX (Pump, Breast, Powered). Since 2016 its 510(k)s took a median of 261 days from receipt to decision, against 141 for FDA’s reviews in the same codes and years. Its devices cite 4 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, obstetrics and gynecology panel, where it files most

How often FDA has decided Ningbo Youhe Electrical Appliance Technology Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2025

2017: 12021: 12025: 2
2017high 2 (2025) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2017.

FIG. 1 — Ningbo Youhe Electrical Appliance Technology Co., Ltd. by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Ningbo Youhe Electrical Appliance…’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?

  • HGXPump, Breast, Powered4decisions

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 261 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 141 days; 1 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 4 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 times; 1 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.

  • K163136Youha electric breast pumpNingbo Youhe Electrical Appliance Technology Co., Ltd. · 20175cite it

What has FDA decided for it lately?

  • K251977electric breast pump (FZ-P8); electric breast pump (YH-P8); electric breast pump (YH-P8X)Ningbo Youhe Electrical Appliance Technology Co., Ltd. · 2025
  • K242725Youha electric breast pumps (The INs, The INs Gen2, The INs NEXT, and P3) and BEBEBAO electric breast pump…Ningbo Youhe Electrical Appliance Technology Co., Ltd. · 2025
  • K203148Youha Electric Breast Pump (Models: THE ONE, YH-8011, YH-8012, YH-8019, YY-5030); Bebebao Electric Breast…Ningbo Youhe Electrical Appliance Technology Co., Ltd. · 2021
  • K163136Youha electric breast pumpNingbo Youhe Electrical Appliance Technology Co., Ltd. · 2017

All 4 as Ningbo Youhe Electrical Appliance Technology Co., Ltd. →