Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Thomas J. Fogarty, M.D. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
89 daysmedian FDA review time
448 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K902453 | OSCILLOMETRIC PULSE DETECTION DEVICE | Thomas J. Fogarty, M.D. | 1990-08-23 | 83 | 0 |
| K884154 | TRANSLUMINAL ENDARTERECTOMY DEVICE | Thomas J. Fogarty, M.D. | 1988-12-27 | 85 | 0 |
| K831809 | FOGARTY OCCLUDER PAD | Thomas J. Fogarty, M.D. | 1984-08-27 | 448 | 0 |
| K841310 | GASTROINTESTINAL DILATOR | Thomas J. Fogarty, M.D. | 1984-07-31 | 123 | 0 |
| K834451 | COAXIAL BALLOON GASTROESOPHAGEAL DILA | Thomas J. Fogarty, M.D. | 1984-02-04 | 47 | 0 |
| K831384 | COAXIAL BALLOON URETHRAL DILATOR | Thomas J. Fogarty, M.D. | 1983-07-26 | 89 | 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