Cleared Traditional

K203347 - Sleep Apnea Breathing Therapy Mask: YF-...

K203347 is an FDA 510(k) clearance for Sleep Apnea Breathing Therapy Mask: YF-..., manufactured by Suzhou Yuyue Medical Technology Co., Ltd.. The device is a Class 2 Anesthesiology device with product code BZD cleared through the Traditional 510(k) pathway after a 231-day FDA review.

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

FDA 510(k) Submission Details - K203347

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.

BZD Device Classification - Class 2, Special Controls

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 291
Devices cleared under the same product code (BZD) and FDA review panel - the closest regulatory comparables to K203347.
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