Not Cleared Post-NSE

DEN120016 - DEKA ARM SYSTEM (FDA 510(k) Clearance)

Class II Physical Medicine device cleared through the Post-NSE 510(k) pathway - typically does not require clinical trials.

DEN120016 · Deka Integrated Solutions Corporation · Physical Medicine device
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May 2014
Decision
693d
Days
Class 2
Risk

DEN120016 is an FDA 510(k) submission (not cleared) for the DEKA ARM SYSTEM. Classified as Upper Extremity Prosthesis With Multiple Simultaneous Degrees Of Freedom And Controlled Via Cutaneous Electromyography (product code PAE), Class II - Special Controls.

Submitted by Deka Integrated Solutions Corporation (Manchester, US). The FDA issued a Not Cleared (DENG) decision on May 9, 2014 after a review of 693 days.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3450 - the FDA physical medicine 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 693 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.

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Submission Details

510(k) Number DEN120016 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received June 15, 2012
Decision Date May 09, 2014
Days to Decision 693 days
Submission Type Post-NSE
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
578d slower than avg
Panel avg: 115d · This submission: 693d
Pathway characteristics

Device Classification

Product Code PAE Upper Extremity Prosthesis With Multiple Simultaneous Degrees Of Freedom And Controlled Via Cutaneous Electromyography
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.3450
Definition Upper Extremity Prosthesis Intended To Replace Partially Or Fully Amputated Or Congenitally Absent Upper Extremities And To Provide Multiple And Simultaneous Degrees Of Freedom And Functionality.
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 Physical Medicine devices follow this clearance model.