510(k) Report

FDA applicant

Guangdong Youkey Medical Co., Ltd.

Foshan, CN2 decisions2022–20240 recalls

FDA records 2 decisions for Guangdong Youkey Medical Co., Ltd. (Foshan, CN) from 2022 to 2024: 2 510(k) clearances. All are in product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic). Its devices cite 2 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, radiology panel, where it files most

How often FDA has decided Guangdong Youkey Medical Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2022: 12024: 1
2022high 1 (2022) · low 0 (2023)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2022.

FIG. 1 — Guangdong Youkey Medical Co., Ltd. by year, 2022–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Guangdong Youkey Medical 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

Which product codes does it file in?

  • IYNSystem, Imaging, Pulsed Doppler, Ultrasonic2decisions

Whose devices does it build on?

Its devices cite 2 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K211746Pocket Ultrasound SystemGuangdong Youkey Medical Co., Ltd. · 20221cites it

What has FDA decided for it lately?

  • K231930Digital Ultrasonic Diagnostic Imaging System (Model: F6)Guangdong Youkey Medical Co., Ltd. · 2024
  • K211746Pocket Ultrasound SystemGuangdong Youkey Medical Co., Ltd. · 2022

All 2 as Guangdong Youkey Medical Co., Ltd. →