510(k) Report

FDA applicant

Dongguanshi Yiyingmei Technology Co., Ltd.

Dongguan, CN2 decisions2024–20240 recalls

FDA records 2 decisions for Dongguanshi Yiyingmei Technology Co., Ltd. (Dongguan, CN) in 2024: 2 510(k) clearances. Most are in product codes BTA (Pump, Portable, Aspiration (Manual Or Powered)) and 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, general and plastic surgery panel, where it files most

How often FDA has decided Dongguanshi Yiyingmei Technology Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2024

2024: 2
2024high 2 (2024) · low 0 (2025)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2024.

FIG. 1 — Dongguanshi Yiyingmei Technology Co., Ltd. by year, 2024–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • BTAPump, Portable, Aspiration (Manual Or Powered)1decision
  • HGXPump, Breast, Powered1decision

Whose devices does it build on?

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

What has FDA decided for it lately?

  • K242028Nasal Aspirator (BC-021, BC-022, BC-023, BC-024, BC-025, BC-026)Dongguanshi Yiyingmei Technology Co., Ltd. · 2024
  • K231969BASEN Wearable Breast Pump (Model: YM-801, YM-803, YM-805, YM-806, YM-808)Dongguanshi Yiyingmei Technology Co., Ltd. · 2024

All 2 as Dongguanshi Yiyingmei Technology Co., Ltd. →