Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Broadwest Corp. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
38 daysmedian FDA review time
82 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K864499 | PODOSCOPE | Broadwest Corp. | 1987-02-04 | 82 | 0 |
| K864569 | PODODIGITAL | Broadwest Corp. | 1987-02-04 | 76 | 0 |
| K852302 | INOX IORCEPS JAR | Broadwest Corp. | 1985-07-02 | 34 | 0 |
| K852301 | INOX THERMOMETER JAR | Broadwest Corp. | 1985-07-01 | 33 | 0 |
| K852300 | INOX IV STAND | Broadwest Corp. | 1985-06-20 | 22 | 0 |
| K851307 | INOX DRY HEAT STERILIZER | Broadwest Corp. | 1985-05-09 | 38 | 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