Not Cleared Direct

DEN200006 - ClearUP Sinus Relief (FDA 510(k) Clearance)

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

DEN200006 · Tivic Health Systems, Inc. · Ear, Nose, Throat device
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Mar 2021
Decision
392d
Days
Class 2
Risk

DEN200006 is an FDA 510(k) submission (not cleared) for the ClearUP Sinus Relief. Classified as Transcutaneous Electrical Nerve Stimulator For The Relief Of Congestion (product code QNU), Class II - Special Controls.

Submitted by Tivic Health Systems, Inc. (Menlo Park, US). The FDA issued a Not Cleared (DENG) decision on March 5, 2021 after a review of 392 days.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.6000 - the FDA ear, nose and throat 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 392 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 Tivic Health Systems, Inc. devices

Submission Details

510(k) Number DEN200006 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received February 07, 2020
Decision Date March 05, 2021
Days to Decision 392 days
Submission Type Direct
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
303d slower than avg
Panel avg: 89d · This submission: 392d
Pathway characteristics

Device Classification

Product Code QNU Transcutaneous Electrical Nerve Stimulator For The Relief Of Congestion
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.6000
Definition A Transcutaneous Electrical Nerve Stimulator For The Relief Of Congestion Is A Device That Electrically Stimulates The Skin Overlying The Paranasal Sinuses To Relieve Congestion.
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 Ear, Nose, Throat devices follow this clearance model.