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..

Clearance details

Applicant: Dcstar, Inc.
Product code: Code BZD
Advisory panel: Anesthesiology
Date received: 2025-06-23
Decision date: 2026-05-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New York, NY, US

Download summary PDF View on FDA.gov ↗

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, 2020-01-01 through 2026-04-23. 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.