Cleared Traditional

Skynector CPAP Mask (K150685) - FDA 510(k) Clearance

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

K150685 · Sky Wise Medical Instrument (Shen Zhen) Co., Ltd. · Anesthesiology device
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Aug 2015
Decision
160d
Days
Class 2
Risk

K150685 is an FDA 510(k) clearance for the Skynector CPAP Mask. Classified as Ventilator, Non-continuous (respirator) (product code BZD), Class II - Special Controls.

Submitted by Sky Wise Medical Instrument (Shen Zhen) Co., Ltd. (Shenzhen, Guang Dong, CN). The FDA issued a Cleared decision on August 24, 2015 after a review of 160 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 Sky Wise Medical Instrument (Shen Zhen) Co., Ltd. devices

Submission Details

510(k) Number K150685 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 2015
Decision Date August 24, 2015
Days to Decision 160 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d slower than avg
Panel avg: 140d · This submission: 160d
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 208
Devices cleared under the same product code (BZD) and FDA review panel - the closest regulatory comparables to K150685.
Simple T Pediatric Nasal Mask
K151120 · Respironics, Inc. · Apr 2016
Sapphire
K152356 · Respironics, Inc. · Jan 2016
AF541 EE Full Face Mask
K150639 · Respironics, Inc. · Sep 2015
Darlinghurst Vented, Darlinghurst NV-AAV
K143603 · Resmed, Ltd. · May 2015
TI NASAL MASK
K140980 · Respironics, Inc. · Feb 2015
Revolution Full Face Mask
K142554 · Respironics, Inc. · Jan 2015