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FDA 510(k)

Sleepiz One+ (Model 2.5)

K-Number: K253388 · 2026-01-28

ApplicantSleepiz AG
Decision Date2026-01-28
Product CodeDRT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Sleepiz One+ (Model 2.5) is the device name listed in this FDA 510(k) record. The listed applicant is Sleepiz AG. It received FDA 510(k) clearance on 2026-01-28 under 510(k) 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. The listed applicant is Sleepiz AG. The 510(k) number is K253388.

When did Sleepiz One+ (Model 2.5) receive FDA 510(k) clearance?

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

Who is the listed applicant for Sleepiz One+ (Model 2.5)?

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

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 records listing Sleepiz AG 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.

K251364Sleepiz One+ (2.5)K223163Sleepiz One+

Related Devices (Code: DRT)

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.

K261286The Circadia C300 System (C300)Circadia Health, Inc.K252676The Circadia C300 System (C300)Circadia Health, Inc.K251364Sleepiz One+ (2.5)Sleepiz AGK234003The Circadia C200 SystemCircadia Technologies, Ltd.K232354Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central Server SoftwareMurata Vios, Inc.K231733Neteera 130H-Plus Vital Sign Monitoring SensorNeteera Technologies , Ltd.

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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