FDA 510(k)

Sonio Suspect

K-Number: K261519 · 2026-06-04

ApplicantSonio

Decision Date2026-06-04

Product CodePOK

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Sonio Suspect is the device name listed in this FDA 510(k) record. The listed applicant is Sonio. It received FDA 510(k) clearance on 2026-06-04 under 510(k) number K261519. The device is classified under product code POK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Sonio Suspect?

Sonio Suspect is a medical device that received FDA 510(k) clearance on 2026-06-04. The listed applicant is Sonio. The 510(k) number is K261519.

When did Sonio Suspect receive FDA 510(k) clearance?

Sonio Suspect received FDA 510(k) clearance on 2026-06-04, under 510(k) number K261519.

Who is the listed applicant for Sonio Suspect?

The FDA 510(k) record lists Sonio as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sonio Suspect?

The FDA product code for Sonio Suspect is POK.

Other records listing Sonio as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252433Sonio Detect (v3)K243614Sonio Suspect K240406Sonio Detect K230365Sonio Detect

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.