FDA applicant

Shangdong Huamei Technology Co., Ltd.

Weifang, CN5 decisions2019–20230 recalls

FDA records 5 decisions for Shangdong Huamei Technology Co., Ltd. (Weifang, CN) from 2019 to 2023: 5 510(k) clearances. Most are in product codes GEX (Powered Laser Surgical Instrument) and ONF (Powered Light Based Non-Laser Surgical…). Since 2016 its 510(k)s took a median of 58 days from receipt to decision, against 89 for FDA’s reviews in the same codes and years. Its devices cite 5 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, general and plastic surgery panel, where it files most

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

FDA decisions per year

1in 2023

2019high 2 (2019) · low 0 (2021)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2019.

FIG. 1 — Shangdong Huamei Technology Co., Ltd. by year, 2019–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Shangdong Huamei Technology Co., Ltd.’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

Other applicant names beginning “Shangdong”

FDA records each applicant name separately; these may or may not be the same firm.

Shangdong Zibo Shanchuan Medical Instruments Co. 2 Shangdong Kangsheng Medical Devices Co., Ltd. 1

Shangdong Huamei Technology Co., Ltd.

Which product codes does it file in?

How long do its 510(k) reviews take?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Shangdong”