510(k) Report

FDA applicant

Guangzhou Sonostar Technologies Co., Ltd.

Guangzhou, CN3 decisions2017–20220 recalls

FDA records 3 decisions for Guangzhou Sonostar Technologies Co., Ltd. (Guangzhou, CN) from 2017 to 2022: 3 510(k) clearances. Most are in product codes IYN (System, Imaging, Pulsed Doppler, Ultrasonic) and IYO (System, Imaging, Pulsed Echo, Ultrasonic). Since 2016 its 510(k)s took a median of 169 days from receipt to decision, against 83 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, radiology panel, where it files most

How often FDA has decided Guangzhou Sonostar Technologies Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2017: 12018: 12022: 1
2017high 1 (2017) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2017.

FIG. 1 — Guangzhou Sonostar Technologies Co., Ltd. by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Guangzhou Sonostar Technologies Co.…’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • IYNSystem, Imaging, Pulsed Doppler, Ultrasonic2decisions
  • IYOSystem, Imaging, Pulsed Echo, Ultrasonic1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 169 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 83 days; 0 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 5 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 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.

  • K172750Wireless Probe Type Ultrasound Scanner (Model:UProbe-C; UProbe-L; BProbe)Guangzhou Sonostar Technologies Co., Ltd. · 20184cite it
  • K171926C5 Diagnostic Ultrasound SystemGuangzhou Sonostar Technologies Co., Ltd. · 20171cites it
  • K211321Wireless Probe Type Ultrasound Scanner (Model: CProbe; Type: Type C, Type L, Type CT, Type CL)Guangzhou Sonostar Technologies Co., Ltd. · 20221cites it

What has FDA decided for it lately?

  • K211321Wireless Probe Type Ultrasound Scanner (Model: CProbe; Type: Type C, Type L, Type CT, Type CL)Guangzhou Sonostar Technologies Co., Ltd. · 2022
  • K172750Wireless Probe Type Ultrasound Scanner (Model:UProbe-C; UProbe-L; BProbe)Guangzhou Sonostar Technologies Co., Ltd. · 2018
  • K171926C5 Diagnostic Ultrasound SystemGuangzhou Sonostar Technologies Co., Ltd. · 2017

All 3 as Guangzhou Sonostar Technologies Co., Ltd. →