FDA product code OPT: Infrared Hematoma Detector
OPT is the FDA product code for infrared hematoma detector. It is a Class II device, regulated under 21 CFR 882.1935 and reviewed by the Neurology panel. FDA has cleared 4 510(k) submissions under OPT, 2 in the last five years. The average 510(k) review took 230 days (median 235); 211 days on average over the last three years. 1 De Novo request was granted under it. FDA has posted 1 recall for OPT devices.
Definition
To employ near-infrared spectroscopy that is intended to be used to evaluate suspected brain hematomas.
Classification
| Field | Value |
|---|---|
| Device name | Infrared Hematoma Detector |
| Device class | Class II |
| Regulation | 21 CFR 882.1935 |
| Review panel | NE — Neurology |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) |
510(k) clearances per year for OPT
| Year | Clearances | Avg. review days |
|---|---|---|
| 2020 | 1 | 164 |
| 2022 | 1 | 259 |
| 2024 | 1 | 211 |
Top OPT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Infrascan, Inc. | 4 | 2024-12-12 |
Most recent OPT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K241389 | Infrascan, Inc. | Infrascanner Model 2500 (Model 2500) | 2024-12-12 | 211 |
| K211617 | Infrascan, Inc. | Infrascanner | 2022-02-09 | 259 |
| K200203 | Infrascan, Inc. | Infrascanner | 2020-07-10 | 164 |
| K120949 | Infrascan, Inc. | INFRASCANNER | 2013-01-11 | 287 |
Recalls for OPT devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2013-10-16.
Frequently asked questions
What is FDA product code OPT?
OPT is the FDA product code for infrared hematoma detector. It is a Class II device, regulated under 21 CFR 882.1935 and reviewed by the Neurology panel.
What device class is OPT?
Class II, regulation 21 CFR 882.1935. Typical premarket route: 510(k).
How long does a 510(k) take for product code OPT?
Across 4 cleared submissions the average was 230 days from receipt to decision (median 235).
Which companies have the most OPT clearances?
Infrascan, Inc. (4).
Have OPT devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2013-10-16.
Next steps
- Run an FDA pathway report with predicate devices for product code OPT
- Run a recall and safety report across every OPT manufacturer
- Watch product code OPT for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.