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FDA 510(k)

MySleepDash

K-Number: K252338 · 2026-04-17

ApplicantSomnetics International, Inc. (Dba Transcend Inc)
Decision Date2026-04-17
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MySleepDash is a medical device manufactured by Somnetics International, Inc. (Dba Transcend Inc). It received FDA 510(k) clearance on 2026-04-17 under approval number K252338. The device is classified under product code BZD. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MySleepDash?

MySleepDash is a medical device that received FDA 510(k) clearance on 2026-04-17. It is manufactured by Somnetics International, Inc. (Dba Transcend Inc). The 510(k) number is K252338.

When was MySleepDash approved by the FDA?

MySleepDash received FDA 510(k) clearance on 2026-04-17, under approval number K252338.

What company makes MySleepDash?

MySleepDash is manufactured by Somnetics International, Inc. (Dba Transcend Inc).

What is the FDA product code for MySleepDash?

The FDA product code for MySleepDash is BZD.

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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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