510(k) · Cleared
ClearedInfrascanner Model 2500 (Model 2500)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Infrascan, Inc. · OPT Infrared Hematoma Detector
Cleared on Dec 12, 2024 as substantially equivalent to K211617 (Infrascan, Inc., 2022) after a 211-day review. Its family tree reaches back 4 generations to 2011.
- Decided
- Dec 12, 2024
- Review
- 211 days
- Class
- Class II
- Product code
- OPT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to DEN100002 (2011). No later device cites it as a predicate yet.
- Root · 4 generations backDEN100002 Infrascanner, Model 1000Infrascan, Inc. · 2011
- 3 generations backK120949 InfrascannerInfrascan, Inc. · 2013
- 2 generations backK200203 InfrascannerInfrascan, Inc. · 2020
- 1 generation backK211617 InfrascannerInfrascan, Inc. · 2022
- This deviceK241389 Infrascanner Model 2500 (Model 2500)Infrascan, Inc. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | DEN100002 | Infrascanner, Model 1000 | Infrascan, Inc. | 2011 | — |
| −3 | K120949 | Infrascanner | Infrascan, Inc. | 2013 | — |
| −2 | K200203 | Infrascanner | Infrascan, Inc. | 2020 | — |
| −1 | K211617 | Infrascanner | Infrascan, Inc. | 2022 | — |
| 0 (this device) | K241389 | Infrascanner Model 2500 (Model 2500) | Infrascan, Inc. | 2024 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in OPT? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new OPT device
- #1 K211617 Infrascannerscore 6.4 · 3 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K211617 | InfrascannerSummary page 5…Product Code OPT Regulatory Class: II III. PREDICATE DEVICE • Infrascan, Inc. Infrascanner Model 2500 cleared under K211617, Product Code: OPT IV. DEVICE DESCRIPTION The device is a noninvasive device, which uses near-infrared spectroscopy… | 2022 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 1 company; a new generation was cleared every 2.8 years on median.
- None of the 4 ancestors has a recall.
How does its category compare?
All OPT devicesOPT Infrared Hematoma Detector: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · OPT
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · OPT
Too few OPT 510(k)s in any year since 2007 to give a median.
Recalls per year · OPT
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OPT
2in 2013
MAUDE reports naming product code OPT, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 1 | 2 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Infrascanner is indicated for the detection of traumatic supratentorial hematomas of as small as 3.5mL and as deep as 2.5 cm from brain surface, but not both at the same time, as an adjunctive device to the clinical evaluation in the acute hospital setting of adult patients and pediatric patients aged 2 years and older with suspected traumatic supratentorial intracranial hematoma. The device is indicated to assess patients for CT scans but should not…
Read the full statement (126 words)
The Infrascanner is indicated for the detection of traumatic supratentorial hematomas of as small as 3.5mL and as deep as 2.5 cm from brain surface, but not both at the same time, as an adjunctive device to the clinical evaluation in the acute hospital setting of adult patients and pediatric patients aged 2 years and older with suspected traumatic supratentorial intracranial hematoma. The device is indicated to assess patients for CT scans but should not serve as a substitute for these scans, the device should only be used to rule in subjects for the presence of hematoma, never to rule out. The Infrascanner is indicated for use by Physicians, or under the direction of a physician, who has been trained in the use of the device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K241389 · printed Nov 5, 2026
Cite this page
510(k) Report. “K241389: Infrascanner Model 2500 (Model 2500).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K241389
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026