510(k) Report

FDA applicant

Sonio

Paris, FR5 decisions2023–20260 recalls

FDA records 5 decisions for Sonio (Paris, FR) from 2023 to 2026: 5 510(k) clearances. Most are in product codes IYN (System, Imaging, Pulsed Doppler, Ultrasonic) and POK (Computer-Assisted Diagnostic Software For…). Since 2016 its 510(k)s took a median of 91 days from receipt to decision, against 119 for FDA’s reviews in the same codes and years. Its devices cite 5 predicates, 3 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 Sonio’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2023: 12024: 12025: 12026 (partial year): 2
2023high 2 (2026) · low 1 (2023)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2023.

FIG. 1 — Sonio by year, 2023–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Sonio’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, Ultrasonic3decisions
  • POKComputer-Assisted Diagnostic Software For Lesions Suspicious For Cancer2decisions

How long do its 510(k) reviews take?

Since 2016, its 5 510(k)s took a median of 91 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 119 days; 3 of its 5 were faster than that.

Whose devices does it build on?

Its devices cite 5 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 7 times; 3 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.

  • K240406Sonio DetectSonio · 20243cite it
  • K230365Sonio DetectSonio · 20233cite it
  • K243614Sonio SuspectSonio · 20251cites it

What has FDA decided for it lately?

All 5 as Sonio →