Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Kuschall of America · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K953427 | CHAMPION, 3000 REBEL | Kuschall of America | 1995-07-31 | 10 | 0 |
| K953428 | CHAMPION, 3000 | Kuschall of America | 1995-07-31 | 10 | 0 |
| K953426 | COMPETITOR | Kuschall of America | 1995-07-31 | 10 | 0 |
| K953429 | CHAMPION, 1000 | Kuschall of America | 1995-07-31 | 11 | 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