Cleared Traditional

DreamWear Silicone Pillows Mask

K210844 · Respironics, Inc. · Anesthesiology
Aug 2021
Decision
155d
Days
Class 2
Risk

About This 510(k) Submission

K210844 is an FDA 510(k) clearance for the DreamWear Silicone Pillows Mask, a Ventilator, Non-continuous (respirator) (Class II — Special Controls, product code BZD), submitted by Respironics, Inc. (Murrysville, US). The FDA issued a Cleared decision on August 24, 2021, 155 days after receiving the submission on March 22, 2021. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5905.

Submission Details

510(k) Number K210844 FDA.gov
FDA Decision Cleared SESE
Date Received March 22, 2021
Decision Date August 24, 2021
Days to Decision 155 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BZD — Ventilator, Non-continuous (respirator)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5905

Similar Devices — BZD Ventilator, Non-continuous (respirator)

All 454
Sleepnet Arie Full Face Vented Mask; Sleepnet Arie Nasal Vented Mask
K251847 · Sleepnet Corporation · Jan 2026
DeltaWave Nasal Pillow System
K253939 · RemSleep Holdings, Inc. · Jan 2026
SleepRes PAP System
K251770 · Sleepres, Inc. · Dec 2025
Personalized Therapy Comfort Settings (PTCS)
K251657 · ResMed Corp · Dec 2025
F&P Nova Nasal Mask
K243583 · Fisher & Paykel Healthcare Limited · Jun 2025
myAir
K250624 · ResMed Corp · May 2025