FDA 510(k)

SOMNUM (SOMNUM)

K-Number: K253390 · 2026-06-27

Decision Date2026-06-27

Product CodeOLZ

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

SOMNUM (SOMNUM) is the device name listed in this FDA 510(k) record. The listed applicant is Honeynaps Co., Ltd.. It received FDA 510(k) clearance on 2026-06-27 under 510(k) number K253390. The device is classified under product code OLZ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SOMNUM (SOMNUM)?

SOMNUM (SOMNUM) is a medical device that received FDA 510(k) clearance on 2026-06-27. The listed applicant is Honeynaps Co., Ltd.. The 510(k) number is K253390.

When did SOMNUM (SOMNUM) receive FDA 510(k) clearance?

SOMNUM (SOMNUM) received FDA 510(k) clearance on 2026-06-27, under 510(k) number K253390.

Who is the listed applicant for SOMNUM (SOMNUM)?

The FDA 510(k) record lists Honeynaps Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SOMNUM (SOMNUM)?

The FDA product code for SOMNUM (SOMNUM) is OLZ.

Other records listing Honeynaps Co., Ltd. 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.

K223922SOMNUM (V.1.1.2.)

Related Devices (Code: OLZ)

K253668Onera SleepMap (SLEEPMAP)Onera B.V.K250851Hypnos (369054-200)Cadwell Industries, Inc.K252330DeepRESPNox Medical Ehf K250058NEAT 001Brain Electrophysiology Laboratory Company, LLC K241960DeepRESPNox Medical Ehf K242094Dreem 3SBeacon Biosignals, Inc.

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.