Not Cleared Direct

DEN170044 - ClearMate (FDA 510(k) Clearance)

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

DEN170044 · Thornhill Research, Inc. · Anesthesiology device
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Mar 2019
Decision
573d
Days
Class 2
Risk

DEN170044 is an FDA 510(k) submission (not cleared) for the ClearMate. Classified as Isocapnic Ventilation Device (product code QFB), Class II - Special Controls.

Submitted by Thornhill Research, Inc. (Toronto, CA). The FDA issued a Not Cleared (DENG) decision on March 14, 2019 after a review of 573 days.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5480 - 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: Regulatory edge-case submission. High predicate equivalence gap. With 573 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

View all Thornhill Research, Inc. devices

Submission Details

510(k) Number DEN170044 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received August 18, 2017
Decision Date March 14, 2019
Days to Decision 573 days
Submission Type Direct
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
434d slower than avg
Panel avg: 139d · This submission: 573d
Pathway characteristics

Device Classification

Product Code QFB Isocapnic Ventilation Device
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5480
Definition An Isocapnic Ventilation Device Is A Prescription Device Used To Administer A Blend Of Carbon Dioxide And Oxygen Gases To A Patient To Induce Hyperventilation. This Device May Be Labeled For Use With Breathing Circuits Made Of Reservoir Bags (21 Cfr 868.5320), Oxygen Cannulas (21 Cfr 868.5340), Masks (21 Cfr 868.5550), Valves (21 Cfr 868.5870), Resuscitation Bags (21 Cfr 868.5915), And/or Tubing (21 Cfr 868.5925).
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.