Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
American Bantex Corp. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
91 daysmedian FDA review time
199 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K042104 | AMERICAN BANTEX, MODEL MS 3 | American Bantex Corp. | 2004-10-21 | 78 | 0 |
| K041963 | AMERICAN BANTEX HUMIDIFIER, DRY, BUBBLE, MODELS B9000, 3 PSI | American Bantex Corp. | 2004-10-20 | 91 | 0 |
| K040754 | AMERICAN BANTEX MS 4 MINI SCOOTER | American Bantex Corp. | 2004-07-23 | 121 | 0 |
| K031711 | TANGO, MODELS, BP1 | American Bantex Corp. | 2003-12-18 | 199 | 0 |
| K963218 | BANTEX SURGICAL LATEX GLOVES- TYPE 1 NATURAL RUBBER LATEX SU | American Bantex Corp. | 1996-10-30 | 75 | 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