FDA 510(k)

Sleepiz One+ (Model 2.5)

K-Number: K253388 · 2026-01-28

Decision Date2026-01-28

Product CodeDRT

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Sleepiz One+ (Model 2.5) is a medical device manufactured by Sleepiz AG. It received FDA 510(k) clearance on 2026-01-28 under approval number K253388. The device is classified under product code DRT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Sleepiz One+ (Model 2.5)?

Sleepiz One+ (Model 2.5) is a medical device that received FDA 510(k) clearance on 2026-01-28. It is manufactured by Sleepiz AG. The 510(k) number is K253388.

When was Sleepiz One+ (Model 2.5) approved by the FDA?

Sleepiz One+ (Model 2.5) received FDA 510(k) clearance on 2026-01-28, under approval number K253388.

What company makes Sleepiz One+ (Model 2.5)?

Sleepiz One+ (Model 2.5) is manufactured by Sleepiz AG.

What is the FDA product code for Sleepiz One+ (Model 2.5)?

The FDA product code for Sleepiz One+ (Model 2.5) is DRT.

Other Devices by Sleepiz AG

K223163Sleepiz One+ K251364Sleepiz One+ (2.5)

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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.