510(k) · Cleared
ClearedInfrascanner
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 Jul 10, 2020 as substantially equivalent to K120949 (Infrascan, Inc., 2013) after a 164-day review. Its family tree reaches back 2 generations to 2011. 2 later devices descend from it.
- Decided
- Jul 10, 2020
- Review
- 164 days
- Class
- Class II
- Product code
- OPT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN100002 (2011). 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backDEN100002 Infrascanner, Model 1000Infrascan, Inc. · 2011
- 1 generation backK120949 InfrascannerInfrascan, Inc. · 2013
- This deviceK200203 InfrascannerInfrascan, Inc. · 2020
- Descendant · cites it directly · 1 of its ownK211617 InfrascannerInfrascan, Inc. · 2022
- Descendant · 2 generations on · 0 of its ownK241389 Infrascanner Model 2500 (Model 2500)Infrascan, Inc. · 2024
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | DEN100002 | Infrascanner, Model 1000 | Infrascan, Inc. | 2011 | — |
| −1 | K120949 | Infrascanner | Infrascan, Inc. | 2013 | — |
| 0 (this device) | K200203 | Infrascanner | Infrascan, Inc. | 2020 | — |
| +1 | K211617 | Infrascanner | Infrascan, Inc. | 2022 | — |
| +2 | K241389 | Infrascanner Model 2500 (Model 2500) | Infrascan, Inc. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
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 K241389 Infrascanner Model 2500 (Model 2500)score 9.4 · 4 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 |
|---|---|---|---|
| * | K120949 | InfrascannerSummary page 4…fication Name OPT (21 C.F.R. §882.1935) Predicate Devices InfraScan Infrascanner Model 2000 (K120949) The Infrascanner is indicated for the detection of traumatic supratento… | 2013 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K211617 | Infrascanner | 2022 | 1 |
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 9 years and passes through 1 company; a new generation was cleared every 7.5 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K211617 (Infrascan, Inc., 2022) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K120949.
How does its category compare?
All OPT devicesOPT Infrared Hematoma Detector: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 greater than 3.5 mL in volume that are less than 2.5 cm from the brain surface, as an adjunctive device to the clinical evaluation in the acute hospital setting of patients 18 years old or greater 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 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K200203 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200203: Infrascanner.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200203
Report an extraction error
Are you the manufacturer?
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