Not Cleared Direct

DEN170089 - Curve Positive Airway Pressure System (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN170089 · Fresca Medical · Anesthesiology device
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Jun 2018
Decision
173d
Days
Class 2
Risk

DEN170089 is an FDA 510(k) submission (not cleared) for the Curve Positive Airway Pressure System. Classified as Positive Airway Pressure System (product code QBY), Class II - Special Controls.

Submitted by Fresca Medical (San Clemente, US). The FDA issued a Not Cleared (DENG) decision on June 5, 2018 after a review of 173 days.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5273 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. This submission did not achieve clearance, indicating the FDA determined the device lacked sufficient predicate equivalence under the Anesthesiology review framework.

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Submission Details

510(k) Number DEN170089 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received December 14, 2017
Decision Date June 05, 2018
Days to Decision 173 days
Submission Type Direct
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
34d slower than avg
Panel avg: 139d · This submission: 173d
Pathway characteristics

Device Classification

Product Code QBY Positive Airway Pressure System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5273
Definition A Positive Airway Pressure Delivery System Is A Prescription Noninvasive Ventilatory Device That Delivers Expiratory Positive Airway Pressure For Patients Suffering From Obstructive Sleep Apnea. The System Also Provides Positive Airway Pressure During Incipient Apnea. The System May Include A Dedicated Flow Generator And A Patient Interface.
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.