De Novo · Granted
GrantedInfrascanner, Model 1000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Infrascan, Inc. · OPT Infrared Hematoma Detector
Granted on Dec 13, 2011 as a new device type through De Novo after a 614-day review. 4 later devices descend from it.
- Decided
- Dec 13, 2011
- Review
- 614 days
- Class
- Class II
- Product code
- OPT
- Recalls
- None
4 later devices descend from it, 1 citing it directly.
- This deviceDEN100002 Infrascanner, Model 1000Infrascan, Inc. · 2011
- Descendant · cites it directly · 3 of its ownK120949 InfrascannerInfrascan, Inc. · 2013
- Descendant · 2 generations on · 2 of its ownK200203 InfrascannerInfrascan, Inc. · 2020
- Descendant · 2 generations on · 1 of its ownK211617 InfrascannerInfrascan, Inc. · 2022
- Descendant · 3 generations on · 0 of its ownK241389 Infrascanner Model 2500 (Model 2500)Infrascan, Inc. · 2024
Most influential descendants
Showing 4 of 4 · See all- K120949InfrascannerInfrascan, Inc. · 2013 · cites it directly3descendants
- K200203InfrascannerInfrascan, Inc. · 2020 · 2 generations on2descendants
- K211617InfrascannerInfrascan, Inc. · 2022 · 2 generations on1descendant
- K241389Infrascanner Model 2500 (Model 2500)Infrascan, Inc. · 2024 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN100002 | Infrascanner, Model 1000 | Infrascan, Inc. | 2011 | — |
| +1 | K120949 | Infrascanner | Infrascan, Inc. | 2013 | — |
| +2 | K200203 | Infrascanner | Infrascan, Inc. | 2020 | — |
| +2 | K211617 | Infrascanner | Infrascan, Inc. | 2022 | — |
| +3 | K241389 | Infrascanner Model 2500 (Model 2500) | Infrascan, Inc. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
Sources: FDA De Novo database (decision fields), 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
- #3 Held for the reportin the report
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K120949 | Infrascanner | 2013 | 3 |
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?
- Of its descendants, K120949 (Infrascan, Inc., 2013) has gone furthest, with 3 descendants of its own.
How does its category compare?
All OPT devicesOPT Infrared Hematoma Detector: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 | — |
https://510kreport.com/device/DEN100002 · printed Nov 3, 2026
Cite this page
510(k) Report. “DEN100002: Infrascanner, Model 1000.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/DEN100002
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026