Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
POM — Predicate Candidate Screening
8 FDA 510(k) clearances under this product code; the 50 most recent screened below.
165 daysmedian FDA review time
377 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K241737 | Sway System Sports Plus | Sway Medical, Inc. | 2025-02-15 | 243 | 0 |
| K231688 | ImPACT Version 4 | Impact Applications, Inc. | 2023-09-16 | 99 | 0 |
| K201376 | ANAM Test System | Vista Lifesciences, Inc. | 2021-03-25 | 303 | 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