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FDA 510(k)

Sleep Apnea Feature (v2.0)

K-Number: K261011 · 2026-07-20

ApplicantSamsung Electronics Co., Ltd.
Decision Date2026-07-20
Product CodeQZW
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Sleep Apnea Feature (v2.0) is the device name listed in this FDA 510(k) record. The listed applicant is Samsung Electronics Co., Ltd.. It received FDA 510(k) clearance on 2026-07-20 under 510(k) number K261011. The device is classified under product code QZW. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Sleep Apnea Feature (v2.0)?

Sleep Apnea Feature (v2.0) is a medical device that received FDA 510(k) clearance on 2026-07-20. The listed applicant is Samsung Electronics Co., Ltd.. The 510(k) number is K261011.

When did Sleep Apnea Feature (v2.0) receive FDA 510(k) clearance?

Sleep Apnea Feature (v2.0) received FDA 510(k) clearance on 2026-07-20, under 510(k) number K261011.

Who is the listed applicant for Sleep Apnea Feature (v2.0)?

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

What is the FDA product code for Sleep Apnea Feature (v2.0)?

The FDA product code for Sleep Apnea Feature (v2.0) is QZW.

Other records listing Samsung Electronics 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.

K242651GM85K242478GF85 (models GF85-3P, GF85-SP)K240909Samsung ECG App v 1.3 (ECG)K230292Samsung ECG Monitor Application with Irregular Heart Rhythm NotificationK222353GM85K220175GM85

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Related Devices (Code: QZW)

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.

K240929Sleep Apnea Notification Feature (SANF)Apple, Inc.

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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