510(k) Report

FDA applicant

Shenzhen Lutejiacheng Technology Co., Ltd.

Shenzhen, CN3 decisions2022–20230 recalls

FDA records 3 decisions for Shenzhen Lutejiacheng Technology Co., Ltd. (Shenzhen, CN) from 2022 to 2023: 3 510(k) clearances. All are in product code HGX (Pump, Breast, Powered). Since 2016 its 510(k)s took a median of 90 days from receipt to decision, against 167 for FDA’s reviews in the same codes and years. 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 Shenzhen Lutejiacheng Technology Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2023

2022: 12023: 2
2022high 2 (2023) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2022.

FIG. 1 — Shenzhen Lutejiacheng 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, Powered3decisions

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 90 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 167 days; 3 of its 3 were faster than that.

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 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.

  • K230776Momcozy Wearable Electric Breast Pump ( Model: S9 Pro, S12 Pro)Shenzhen Lutejiacheng Technology Co., Ltd. · 20231cites it

What has FDA decided for it lately?

  • K230776Momcozy Wearable Electric Breast Pump ( Model: S9 Pro, S12 Pro)Shenzhen Lutejiacheng Technology Co., Ltd. · 2023
  • K223693Electric breast pump (model: M5)Shenzhen Lutejiacheng Technology Co., Ltd. · 2023
  • K220309Wearable Breast Pump (Model S10)Shenzhen Lutejiacheng Technology Co., Ltd. · 2022

All 3 as Shenzhen Lutejiacheng Technology Co., Ltd. →