510(k) Report

FDA applicant

Vinno Technology (Suzhou) Co.,Ltd

Suzhou, CN6 decisions2020–20240 recalls

FDA records 6 decisions for Vinno Technology (Suzhou) Co.,Ltd (Suzhou, CN) from 2020 to 2024: 6 510(k) clearances. All are in product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic). Since 2016 its 510(k)s took a median of 172 days from receipt to decision, against 115 for FDA’s reviews in the same codes and years. Its devices cite 8 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 Vinno Technology (Suzhou) Co.,Ltd’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2020: 12022: 12023: 32024: 1
2020high 3 (2023) · low 0 (2021)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2020.

FIG. 1 — Vinno Technology (Suzhou) Co.,Ltd by year, 2020–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Vinno Technology (Suzhou) 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, Ultrasonic6decisions

How long do its 510(k) reviews take?

Since 2016, its 6 510(k)s took a median of 172 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 115 days; 0 of its 6 were faster than that.

Whose devices does it build on?

Its devices cite 8 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.

  • K190120Vinno 8, Vinno 6, Vinno 5Vinno Technology (Suzhou) Co.,Ltd · 20201cites it

What has FDA decided for it lately?

  • K240676ULTIMUS Series Ultrasound Diagnostic SystemVinno Technology (Suzhou) Co.,Ltd · 2024
  • K230160Vinno G86,Vinno G86E,Vinno G65,Vinno G65P,Vinno G65E,Vinno G65D,Vinno M86, Vinno M86E,Vinno G90,Vinno G90EVinno Technology (Suzhou) Co.,Ltd · 2023
  • K223920Vinno G50, Vinno G55, Vinno M50, Vinno E30, Vinno X5, Vinno X6, Vinno X7, Vinno M55, Vinno E35, Vinno X65…Vinno Technology (Suzhou) Co.,Ltd · 2023
  • K223917Vinno E20, Vinno E10,Vinno E10P,Vinno E10E, Vinno X1,Vinno X1E,Vinno X1P, Vinno X2,Vinno X2E,Vinno X2PVinno Technology (Suzhou) Co.,Ltd · 2023
  • K221911Vinno 6PRO, Vinno 6EXP, Vinno 5PRO, Vinno 5EXP, Vinno 3, Vinno 3PRO, Vinno 3EXPVinno Technology (Suzhou) Co.,Ltd · 2022
  • K190120Vinno 8, Vinno 6, Vinno 5Vinno Technology (Suzhou) Co.,Ltd · 2020

All 6 as Vinno Technology (Suzhou) Co.,Ltd →