Impact Applications, Inc.: FDA clearances and approvals
Impact Applications, Inc. has 5 FDA 510(k) clearances (first 2017, latest 2023), plus 1 De Novo decision, across 1 product code in 1 review panel. Median 510(k) review time: 116 days. Since 2017 its median was 116 days, against 117 days for all cleared 510(k)s in the same product codes. It is the industry lead sponsor of 1 device clinical trial on ClinicalTrials.gov.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2017 | 2 | 74 |
| 2018 | 1 | 165 |
| 2019 | 0 | — |
| 2020 | 1 | 116 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 1 | 99 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Impact Applications, Inc.'s cleared 510(k)s took a median 116 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 117 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| POM | Computerized Cognitive Assessment Aid For Concussion | 6 | 5 |
Review panels
- Neurology (6)
Most recent Impact Applications, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K231688 | ImPACT Version 4 | POM | 2023-09-16 | 99 |
| K202485 | ImPACT Version 4 | POM | 2020-12-25 | 116 |
| K181223 | ImPACT | POM | 2018-10-20 | 165 |
| K170551 | ImPACT Quick Test | POM | 2017-06-21 | 117 |
| K170209 | ImPACT | POM | 2017-02-23 | 30 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN150037 | De Novo | Computerized Cognitive Assessment Aid For Concussion | 2016-08-22 |
Recalls
openFDA lists no recalls under a recalling firm named Impact Applications, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Device clinical trials
Impact Applications, Inc. is the industry lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT02701842: ImPACT Online Clinical Study (Completed, started 2016-02)
Frequently asked questions
How many FDA 510(k) clearances does Impact Applications, Inc. have?
Impact Applications, Inc. has 5 FDA 510(k) clearances (first 2017, latest 2023), plus 1 De Novo decision, across 1 product code in 1 review panel.
How long does FDA take to clear Impact Applications, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Impact Applications, Inc.'s cleared 510(k)s is 116 days. Since 2017: 116 days, versus 117 days for all cleared 510(k)s in the same product codes.
What devices does Impact Applications, Inc. make?
Its most frequent FDA product codes are POM (Computerized Cognitive Assessment Aid For Concussion, 6).
Has Impact Applications, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Impact Applications, Inc. Related entities may recall under other names.
Next steps
- See all 5 Impact Applications, Inc. clearances with predicates and recalls
- Run predicate analysis for product code POM, Impact Applications, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.