Cleared Traditional

K241389 - Infrascanner Model 2500 (Model 2500)

K241389 is an FDA 510(k) clearance for Infrascanner Model 2500 (Model 2500), manufactured by Infrascan, Inc.. The device is a Class 2 Neurology device with product code OPT cleared through the Traditional 510(k) pathway after a 211-day FDA review.

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

FDA 510(k) Submission Details - K241389

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.

OPT Device Classification - Class 2, Special Controls

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.