Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Bell Intl., Inc. · Predicate Candidate Screening
2 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K964860 | MARK 20 AND MARK 25 HAND ENGINE CONTROLLER | Bell Intl., Inc. | 1997-03-03 | 89 | 0 |
| K964863 | MODEL 45E HANDENGINE & CONTROLLER, MODEL 45EH HANDENGINE & C | Bell Intl., Inc. | 1997-02-28 | 86 | 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