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FDA 510(k)

Sleep Apnea Breathing Therapy Mask:JoyMask 20-B Full Face Mask, JoyMask 21-B Full Face Mask

K-Number: K251920 · 2026-05-21

ApplicantDcstar, Inc.
Decision Date2026-05-21
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Sleep Apnea Breathing Therapy Mask:JoyMask 20-B Full Face Mask, JoyMask 21-B Full Face Mask is the device name listed in this FDA 510(k) record. The listed applicant is Dcstar, Inc.. It received FDA 510(k) clearance on 2026-05-21 under 510(k) number K251920. 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 Sleep Apnea Breathing Therapy Mask:JoyMask 20-B Full Face Mask, JoyMask 21-B Full Face Mask?

Sleep Apnea Breathing Therapy Mask:JoyMask 20-B Full Face Mask, JoyMask 21-B Full Face Mask is a medical device that received FDA 510(k) clearance on 2026-05-21. The listed applicant is Dcstar, Inc.. The 510(k) number is K251920.

When did Sleep Apnea Breathing Therapy Mask:JoyMask 20-B Full Face Mask, JoyMask 21-B Full Face Mask receive FDA 510(k) clearance?

Sleep Apnea Breathing Therapy Mask:JoyMask 20-B Full Face Mask, JoyMask 21-B Full Face Mask received FDA 510(k) clearance on 2026-05-21, under 510(k) number K251920.

Who is the listed applicant for Sleep Apnea Breathing Therapy Mask:JoyMask 20-B Full Face Mask, JoyMask 21-B Full Face Mask?

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

What is the FDA product code for Sleep Apnea Breathing Therapy Mask:JoyMask 20-B Full Face Mask, JoyMask 21-B Full Face Mask?

The FDA product code for Sleep Apnea Breathing Therapy Mask:JoyMask 20-B Full Face Mask, JoyMask 21-B Full Face Mask is BZD.

Related Clinical Trials

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.

NCT06050720Sleep Apnoea Breathing Record Exploratory Study (SABRES)COMPLETEDNCT07204223Tulip Airway in Difficult Mask Ventilation (TADMV)RECRUITINGNCT07524517NeoSHARK: Anatomical Versus Round Facemasks for Breathing Support in Preterm and Term Newborn InfantsRECRUITINGNCT07600333CPAP vs High-Flow Nasal Cannula for Treating Sleep Apnea in ChildrenNOT_YET_RECRUITINGNCT07677332Mandibular Advancement Device (MAD) and Continuous Positive Airway Pressure (CPAP) for Treatment of Adult Patients Diagnosed With Moderate Obstructive Sleep ApneaNOT_YET_RECRUITINGNCT04607343Clinical Trial of a Rehabilitation Device Based on Electrostimulation for Obstructive Sleep ApnoeaSUSPENDED

Other records listing Dcstar, Inc. 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.

K251628Mandibular Advancement Device L07

Related Devices (Code: BZD)

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.

K253044RXiBreeze PAP System (RXiBreeze 20C)Resvent Medical Technology Co., Ltd.K253553OrionResmed CorpK254104ResScan EssentialsResmed CorpK253166F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S)BMC Medical Co., Ltd.K252338MySleepDashSomnetics International, Inc. (Dba Transcend Inc)K251847Sleepnet Arie Full Face Vented Mask; Sleepnet Arie Nasal Vented MaskSleepnet Corporation

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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