Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Am Scooters · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K922338 | X-330/SPIRIT MOTORIZED THREE-WHEELED SCOOTER | Am Scooters | 1992-06-11 | 23 | 0 |
| K921467 | DRAKE & DRAKE/200 DL | Am Scooters | 1992-04-29 | 33 | 0 |
| K913989 | 510 DL POWERED WHEELCHAIRS | Am Scooters | 1991-10-24 | 49 | 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