510(k) Report

FDA applicant

Suzhou Peaksonic Medical Technology Co., Ltd.

Suzhou, CN2 decisions2021–20220 recalls

FDA records 2 decisions for Suzhou Peaksonic Medical Technology Co., Ltd. (Suzhou, CN) from 2021 to 2022: 2 510(k) clearances. All are in product code IYO (System, Imaging, Pulsed Echo, Ultrasonic). 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, radiology panel, where it files most

How often FDA has decided Suzhou Peaksonic Medical Technology Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2021: 12022: 1
2021high 1 (2021) · low 0 (2023)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2021.

FIG. 1 — Suzhou Peaksonic Medical Technology Co., Ltd. by year, 2021–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • IYOSystem, Imaging, Pulsed Echo, Ultrasonic2decisions

Whose devices does it build on?

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

Who builds on its devices?

Later devices cite its devices 2 times; 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.

  • K201316Bladder Scanner (Model: M3, M3-HD, M4, M4-HD)Suzhou Peaksonic Medical Technology Co., Ltd. · 20212cite it

What has FDA decided for it lately?

  • K213488Bladder Scanner, Model Name:M5Suzhou Peaksonic Medical Technology Co., Ltd. · 2022
  • K201316Bladder Scanner (Model: M3, M3-HD, M4, M4-HD)Suzhou Peaksonic Medical Technology Co., Ltd. · 2021

All 2 as Suzhou Peaksonic Medical Technology Co., Ltd. →