FDA 510(k)

Sonio Detect (v3)

K-Number: K252433 · 2026-03-16

ApplicantSonio

Decision Date2026-03-16

Product CodeIYN

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Sonio Detect (v3) is the device name listed in this FDA 510(k) record. The listed applicant is Sonio. It received FDA 510(k) clearance on 2026-03-16 under 510(k) number K252433. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Sonio Detect (v3)?

Sonio Detect (v3) is a medical device that received FDA 510(k) clearance on 2026-03-16. The listed applicant is Sonio. The 510(k) number is K252433.

When did Sonio Detect (v3) receive FDA 510(k) clearance?

Sonio Detect (v3) received FDA 510(k) clearance on 2026-03-16, under 510(k) number K252433.

Who is the listed applicant for Sonio Detect (v3)?

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 Detect (v3)?

The FDA product code for Sonio Detect (v3) is IYN.

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.

K261519Sonio Suspect K243614Sonio Suspect K240406Sonio Detect K230365Sonio Detect

Related Devices (Code: IYN)

Official Source

View on FDA Database →

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