Not Cleared Direct

DEN220025 - Phagenyx System (FDA 510(k) Clearance)

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

DEN220025 · Phagenesis Limited · Ear, Nose, Throat device
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Sep 2022
Decision
150d
Days
Class 2
Risk

DEN220025 is an FDA 510(k) submission (not cleared) for the Phagenyx System. Classified as Oropharyngeal Electrical Stimulator (product code QQG), Class II - Special Controls.

Submitted by Phagenesis Limited (Manchester, GB). The FDA issued a Not Cleared (DENG) decision on September 16, 2022 after a review of 150 days.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.5950 - 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: 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 Ear, Nose, Throat review framework.

View all Phagenesis Limited devices

Submission Details

510(k) Number DEN220025 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received April 19, 2022
Decision Date September 16, 2022
Days to Decision 150 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
61d slower than avg
Panel avg: 89d · This submission: 150d
Pathway characteristics

Device Classification

Product Code QQG Oropharyngeal Electrical Stimulator
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.5950
Definition An Oropharyngeal Electrical Stimulator Is A Device That Stimulates Afferent Nerve Fibers Of Oropharyngeal Mucosa. The Device Is Intended To Treat Swallowing Dysfunction. The Device May Incorporate A Feeding Tube.
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.