DeviceClearance

Sleep Apnea Breathing Therapy Mask:JoyMask 20-B Full Face Mask, JoyMask 21-B Full Face Mask— 510(k) K251920

Substantially Equivalent

Dcstar, Inc.

FDA 510(k) clearance K251920 for Sleep Apnea Breathing Therapy Mask:JoyMask 20-B Full Face Mask, JoyMask 21-B Full Face Mask, Substantially Equivalent on 2026-05-21. Applicant: Dcstar, Inc.. Device class: 2.

Summary

Dcstar's record is titled "Sleep Apnea Breathing Therapy Mask" and lists two models, the JoyMask 20-B Full Face Mask and the JoyMask 21-B Full Face Mask. The product code is BZD, non-continuous ventilators (respirators).

Class II, 21 CFR 868.5905. Anesthesiology is both the classification panel and the review panel, and it was a Traditional 510(k).

Dcstar filed from New York, New York. Review took 332 calendar days (June 23, 2025 to May 21, 2026).

Clearance details

Applicant
Dcstar, Inc.
Product code
Product code BZD
Device class
Class 2
Regulation
21 CFR 868.5905
Advisory panel
Anesthesiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
New York, NY, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code BZD

product code BZD
Death
4,440
Injury
53,099
Malfunction
213,222
Other
17
Total
270,778

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.