OPT · Class II · 21 CFR 882.1935

FDA Product Code OPT: Infrared Hematoma Detector

To Employ Near-infrared Spectroscopy That Is Intended To Be Used To Evaluate Suspected Brain Hematomas.

Leading manufacturers include Infrascan, Inc..

5
Total
4
Cleared
307d
Avg days
2011
Since
Growing category - 1 submissions in the last 2 years vs 0 in the prior period
Review times improving: avg 211d recently vs 331d historically

FDA 510(k) Cleared Infrared Hematoma Detector Devices (Product Code OPT)

5 devices
1–5 of 5
Cleared Dec 12, 2024
Infrascanner Model 2500 (Model 2500)
K241389
Infrascan, Inc.
Neurology · 211d
Cleared Feb 09, 2022
Infrascanner
K211617
Infrascan, Inc.
Neurology · 259d

About Product Code OPT - Regulatory Context

510(k) Submission Activity

5 total 510(k) submissions under product code OPT since 2011, with 4 receiving FDA clearance (average review time: 307 days).

Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

FDA Review Time

Recent submissions under OPT have taken an average of 211 days to reach a decision - down from 331 days historically, suggesting improved FDA processing for this classification.

OPT devices are reviewed by the Neurology panel. Browse all Neurology devices →