Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Burke Mobility Products — 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) |
|---|---|---|---|---|---|
| K954974 | PACE SAVER LITTLE JUNIOR (MODIFICATION) | Burke Mobility Products | 1996-03-19 | 146 | 0 |
| K925122 | PACE SAVER LITTLE JR | Burke Mobility Products | 1994-03-30 | 537 | 0 |
| K925576 | BURKE BARIATRIC TREATMENT SYSTEM II | Burke Mobility Products | 1993-06-04 | 213 | 0 |
| K900738 | BOOSTER MOTORIZED THREE WHEELED VEHICLE | Burke Mobility Products | 1990-02-22 | 6 | 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