Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Impact Applications, Inc. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
117 daysmedian FDA review time
377 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K231688 | ImPACT Version 4 | Impact Applications, Inc. | 2023-09-16 | 99 | 0 |
| K202485 | ImPACT Version 4 | Impact Applications, Inc. | 2020-12-25 | 116 | 0 |
| K181223 | ImPACT | Impact Applications, Inc. | 2018-10-20 | 165 | 0 |
| K170551 | ImPACT Quick Test | Impact Applications, Inc. | 2017-06-21 | 117 | 0 |
| K170209 | ImPACT | Impact Applications, Inc. | 2017-02-23 | 30 | 0 |
| DEN150037 | ImPACT Computerized Neurocognitive Concussion Management Aid | Impact Applications, Inc. | 2016-08-22 | 377 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda