Not Cleared Post-NSE

DEN100002 - INFRASCANNER, MODEL 1000 (FDA 510(k) Clearance)

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

DEN100002 · Infrascan, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2011
Decision
614d
Days
Class 2
Risk

DEN100002 is an FDA 510(k) submission (not cleared) for the INFRASCANNER, MODEL 1000. Classified as Infrared Hematoma Detector (product code OPT), Class II - Special Controls.

Submitted by Infrascan, Inc. (Philadelphia, US). The FDA issued a Not Cleared (DENG) decision on December 13, 2011 after a review of 614 days.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1935 - 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 614 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 Infrascan, Inc. devices

Submission Details

510(k) Number DEN100002 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received April 08, 2010
Decision Date December 13, 2011
Days to Decision 614 days
Submission Type Post-NSE
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
466d slower than avg
Panel avg: 148d · This submission: 614d
Pathway characteristics

Device Classification

Product Code OPT Infrared Hematoma Detector
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1935
Definition To Employ Near-infrared Spectroscopy That Is Intended To Be Used To Evaluate Suspected Brain Hematomas.
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.