Cleared Traditional

K211274 - iQ 2 Nasal Mask, Phantom 2 Nasal Mask

K211274 is an FDA 510(k) clearance for iQ 2 Nasal Mask, manufactured by Sleepnet Corporation. The device is a Class 2 Anesthesiology device with product code BZD cleared through the Traditional 510(k) pathway after a 258-day FDA review.

K211274 · Sleepnet Corporation · Anesthesiology device
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Jan 2022
Decision
258d
Days
Class 2
Risk

K211274 is an FDA 510(k) clearance for the iQ 2 Nasal Mask, Phantom 2 Nasal Mask. Classified as Ventilator, Non-continuous (respirator) (product code BZD), Class II - Special Controls.

Submitted by Sleepnet Corporation (Hampton, US). The FDA issued a Cleared decision on January 10, 2022 after a review of 258 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 Sleepnet Corporation devices

FDA 510(k) Submission Details - K211274

510(k) Number K211274 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 2021
Decision Date January 10, 2022
Days to Decision 258 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
118d slower than avg
Panel avg: 140d · This submission: 258d
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 Consultant

Sleepnet Corporation % Promedic, LLC
Paul Dryden

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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

All 391
Devices cleared under the same product code (BZD) and FDA review panel - the closest regulatory comparables to K211274.
Luna G3 BPAP System
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Auto CPAP System
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DreamWear Silicone Pillows Mask
K210844 · Respironics, Inc. · Aug 2021
Magneto Nasal Mask
K210386 · Respironics, Inc. · Jul 2021
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 · Suzhou Yuyue Medical Technology Co., Ltd. · Jul 2021