Cleared Traditional

K141208 - DYNAMIC NEUROSCREENING DEVICE (FDA 510(k) Clearance)

Class I Neurology device.

K141208 · Prosenex · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2014
Decision
75d
Days
Class 1
Risk

K141208 is an FDA 510(k) clearance for the DYNAMIC NEUROSCREENING DEVICE. Classified as Test, Temperature Discrimination (product code LQW), Class I - General Controls.

Submitted by Prosenex (Leola, US). The FDA issued a Cleared decision on July 23, 2014 after a review of 75 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1200 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Prosenex devices

Submission Details

510(k) Number K141208 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 2014
Decision Date July 23, 2014
Days to Decision 75 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 148d · This submission: 75d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LQW Test, Temperature Discrimination
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 882.1200
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.