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JoyMask 20-B Full Face Mask, JoyMask 21-B Full Face Mask

by Dcstar, Inc.

510(k) K251920

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK251920 Date21 May 2026ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

Full name
Sleep Apnea Breathing Therapy Mask:JoyMask 20-B Full Face Mask, JoyMask 21-B Full Face Mask
510(k) Number
FDA Product Code
BZD
Device Class
Class II
Regulation
21 CFR Part 868.5905
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The JoyMask 20-B and 21-B are non-invasive sleep apnea breathing therapy masks designed to channel airflow from a positive airway pressure device, such as a CPAP or bi-level system, to the patient. These full face masks cover both the mouth and nose to facilitate therapy.

These devices are intended for single-patient reuse in the home environment by patients weighing over 30kg. They have received FDA 510(k) clearance under K251920 and are classified as Class 2 medical devices.

Other devices from Dcstar, Inc.