Not Cleared Direct

DEN130019 - ZANZA-CLICK (FDA 510(k) Clearance)

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

DEN130019 · Tecnimed S.R.L. · Neurology device
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Nov 2014
Decision
617d
Days
Class 2
Risk

DEN130019 is an FDA 510(k) submission (not cleared) for the ZANZA-CLICK. Classified as Piezo-electric Stimulator For Relief Of Mosquito Bite Itch (product code OSG), Class II - Special Controls.

Submitted by Tecnimed S.R.L. (Ormond Beach, US). The FDA issued a Not Cleared (DENG) decision on November 7, 2014 after a review of 617 days.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5894 - the FDA neurology 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 617 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 Tecnimed S.R.L. devices

Submission Details

510(k) Number DEN130019 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received February 28, 2013
Decision Date November 07, 2014
Days to Decision 617 days
Submission Type Direct
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
469d slower than avg
Panel avg: 148d · This submission: 617d
Pathway characteristics

Device Classification

Product Code OSG Piezo-electric Stimulator For Relief Of Mosquito Bite Itch
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5894
Definition Relief / Reduction Of Mosquito Bite Itch
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 Neurology devices follow this clearance model.