Cleared Traditional

Sleep Apnea Breathing Therapy Mask: YF-01 Full Face Mask, YF-02 Full Face Mask, YF-03 Full Face Mask, YN-02 Nasal Mask, YN-03 Nasal Mask, YP-01 Nasal Pillow Mask (K203347) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K203347 · Suzhou Yuyue Medical Technology Co., Ltd. · Anesthesiology device
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Jul 2021
Decision
231d
Days
Class 2
Risk

K203347 is an FDA 510(k) clearance for the Sleep Apnea Breathing Therapy Mask: YF-01 Full Face Mask, YF-02 Full Face Mas.... Classified as Ventilator, Non-continuous (respirator) (product code BZD), Class II - Special Controls.

Submitted by Suzhou Yuyue Medical Technology Co., Ltd. (Suzhou, CN). The FDA issued a Cleared decision on July 2, 2021 after a review of 231 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5905 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Suzhou Yuyue Medical Technology Co., Ltd. devices

Submission Details

510(k) Number K203347 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 2020
Decision Date July 02, 2021
Days to Decision 231 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
91d slower than avg
Panel avg: 140d · This submission: 231d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code BZD Ventilator, Non-continuous (respirator)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5905
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Peers - BZD Ventilator, Non-continuous (respirator)

All 130
Devices cleared under the same product code (BZD) and FDA review panel - the closest regulatory comparables to K203347.
iQ 2 Nasal Mask, Phantom 2 Nasal Mask
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DreamWear Silicone Pillows Mask
K210844 · Respironics, Inc. · Aug 2021
Magneto Nasal Mask
K210386 · Respironics, Inc. · Jul 2021
Innova Nasal Non-Vented Mask
K203601 · Sleepnet Corporation · Apr 2021
Luna® G3 BPAP 25A
K201620 · 3B Medical, Inc. · Jan 2021
Galapogos
K200565 · ResMed Corp · Jan 2021