Infrascan, Inc.: FDA filings under this applicant name
FDA lists 4 510(k) clearances under the applicant name “Infrascan, Inc.” (first 2013, latest 2024), plus 1 De Novo decision, across 1 product code in 1 review panel. Median 510(k) review time under this name: 235 days. Since 2017 the median was 211 days, against 211 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2013 | 1 | 287 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 1 | 164 |
| 2021 | 0 | — |
| 2022 | 1 | 259 |
| 2023 | 0 | — |
| 2024 | 1 | 211 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Infrascan, Inc. took a median 211 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 211 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| OPT | Infrared Hematoma Detector | 5 | 4 |
Review panels
- Neurology (5)
Most recent Infrascan, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K241389 | Infrascanner Model 2500 (Model 2500) | OPT | 2024-12-12 | 211 |
| K211617 | Infrascanner | OPT | 2022-02-09 | 259 |
| K200203 | Infrascanner | OPT | 2020-07-10 | 164 |
| K120949 | INFRASCANNER | OPT | 2013-01-11 | 287 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN100002 | De Novo | Infrared Hematoma Detector | 2011-12-13 |
Recalls
openFDA lists no recalls under a recalling firm named Infrascan, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Infrascan, Inc. is the lead sponsor of 2 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:
- NCT07014748: SAFETY: Stabilization Points to Third Hospital Line Assessment oF the Impact of the usE of Infrascanner Model 2500 to Provide Decision Support for Diagnosis/Screening of Traumatic Brain InjurY in Ukraine (Recruiting, started 2025-01-17)
- NCT00576147: A Multi-Center Study of Near-Infrared Spectroscopy (NIRS) for Hematoma Detection (Completed, started 2006-07)
Frequently asked questions
How many FDA 510(k) clearances are listed under Infrascan, Inc.?
FDA lists 4 510(k) clearances under the applicant name “Infrascan, Inc.” (first 2013, latest 2024), plus 1 De Novo decision, across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Infrascan, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Infrascan, Inc. is 235 days. Since 2017: 211 days, versus 211 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Infrascan, Inc.?
The most frequent FDA product codes under this applicant name are OPT (Infrared Hematoma Detector, 5).
Next steps
- See all 4 Infrascan, Inc. clearances with predicates and recalls
- Run predicate analysis for product code OPT, Infrascan, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.