Not Cleared Direct

DEN210055 - The N-SWEAT Patch (FDA 510(k) Clearance)

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

DEN210055 · Candesant Biomedical, Inc. · General & Plastic Surgery device
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Apr 2023
Decision
490d
Days
Class 2
Risk

DEN210055 is an FDA 510(k) submission (not cleared) for the The N-SWEAT Patch. Classified as Skin Patch For Treatment Of Hyperhidrosis (product code QVX), Class II - Special Controls.

Submitted by Candesant Biomedical, Inc. (San Francisco, US). The FDA issued a Not Cleared (DENG) decision on April 7, 2023 after a review of 490 days.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4425 - the FDA general and plastic surgery 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 490 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 Candesant Biomedical, Inc. devices

Submission Details

510(k) Number DEN210055 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received December 03, 2021
Decision Date April 07, 2023
Days to Decision 490 days
Submission Type Direct
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
376d slower than avg
Panel avg: 114d · This submission: 490d
Pathway characteristics

Device Classification

Product Code QVX Skin Patch For Treatment Of Hyperhidrosis
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4425
Definition A Skin Patch For Treatment Of Hyperhidrosis Is A Prescription Topical Patch That Utilizes A Chemical Reaction To Generate Thermal Energy In Situ For Treatment Of Hyperhidrosis.
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 General & Plastic Surgery devices follow this clearance model.