Not Cleared Direct

DEN170001 - Precision Flow® HVNI (FDA 510(k) Clearance)

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

DEN170001 · Vapotherm, Inc. · Anesthesiology device
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Apr 2018
Decision
462d
Days
Class 2
Risk

DEN170001 is an FDA 510(k) submission (not cleared) for the Precision Flow® HVNI. Classified as High Flow/high Velocity Humidified Oxygen Delivery Device (product code QAV), Class II - Special Controls.

Submitted by Vapotherm, Inc. (Exeter, US). The FDA issued a Not Cleared (DENG) decision on April 10, 2018 after a review of 462 days.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5454 - 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 462 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 Vapotherm, Inc. devices

Submission Details

510(k) Number DEN170001 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received January 03, 2017
Decision Date April 10, 2018
Days to Decision 462 days
Submission Type Direct
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
323d slower than avg
Panel avg: 139d · This submission: 462d
Pathway characteristics

Device Classification

Product Code QAV High Flow/high Velocity Humidified Oxygen Delivery Device
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5454
Definition Intended To Deliver High Flow And/or High Velocity Oxygen With Humidification.
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.