Cleared Traditional

K241389 - Infrascanner Model 2500 (Model 2500) (FDA 510(k) Clearance)

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K241389 · Infrascan, Inc. · Neurology device
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Dec 2024
Decision
211d
Days
Class 2
Risk

K241389 is an FDA 510(k) clearance for the Infrascanner Model 2500 (Model 2500). Classified as Infrared Hematoma Detector (product code OPT), Class II - Special Controls.

Submitted by Infrascan, Inc. (Philadelphia, US). The FDA issued a Cleared decision on December 12, 2024 after a review of 211 days - an extended review cycle.

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 establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Infrascan, Inc. devices

Submission Details

510(k) Number K241389 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 2024
Decision Date December 12, 2024
Days to Decision 211 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
63d slower than avg
Panel avg: 148d · This submission: 211d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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.