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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 a medical device manufactured by Sonio. It received FDA 510(k) clearance on 2026-03-16 under approval 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. It is manufactured by Sonio. The 510(k) number is K252433.

When was Sonio Detect (v3) approved by the FDA?

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

What company makes Sonio Detect (v3)?

Sonio Detect (v3) is manufactured by Sonio.

What is the FDA product code for Sonio Detect (v3)?

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

Other Devices by Sonio

K230365Sonio Detect K240406Sonio Detect K243614Sonio Suspect

Related Devices (Code: IYN)

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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.

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