Cleared Traditional

K150685 - Skynector CPAP Mask

K150685 is an FDA 510(k) clearance for Skynector CPAP Mask, manufactured by Sky Wise Medical Instrument (Shen Zhen) Co., Ltd.. The device is a Class 2 Anesthesiology device with product code BZD cleared through the Traditional 510(k) pathway after a 160-day FDA review.

K150685 · Sky Wise Medical Instrument (Shen Zhen) Co., Ltd. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K150685

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
Combination Product No
PCCP Authorized No
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.

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 458
Devices cleared under the same product code (BZD) and FDA review panel - the closest regulatory comparables to K150685.
DeVilbiss Intellipap2/DeVilbiss BLUE
K143677 · Devilbiss Healthcare, LLC · Sep 2015
AF541 EE Full Face Mask
K150639 · Respironics, Inc. · Sep 2015
Apex Medical Corp. iCH CPAP with PVA 9S-007XXX Series
K150111 · Apex Medical Corp. · Sep 2015
CPAP Cannulaide
K143700 · Salter Labs · Aug 2015
Cloud9 System
K150365 · Insleep Technologies, LLC · Jul 2015
Darlinghurst Vented, Darlinghurst NV-AAV
K143603 · Resmed, Ltd. · May 2015
K150685 · Skynector CPAP Mask
Download PDF FDA Summary Sky Wise Medical Inst…