Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Bryan Corp. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
127 daysmedian FDA review time
431 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K002063 | BIOTRACE, MODEL 1730 | Bryan Corp. | 2000-08-10 | 34 | 0 |
| K913242 | MICROPROCESSED CONTROLLED LAPAROFLATOR | Bryan Corp. | 1992-09-25 | 431 | 0 |
| K894380 | DUMON TRACHEOBRONCHIAL STENT | Bryan Corp. | 1989-10-24 | 99 | 0 |
| K881249 | BAGGISH, HYSTEROSCOPE | Bryan Corp. | 1988-07-28 | 127 | 0 |
| K854414 | DUMON/HARRELL | Bryan Corp. | 1986-03-12 | 128 | 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