Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Frederic J. Toye, M.D. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
79 daysmedian FDA review time
794 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K871199 | MODIFIED PERTRACH DISP. PEDIATRIC PERCUT. TRACHEO. | Frederic J. Toye, M.D. | 1987-06-08 | 75 | 0 |
| K822440 | PERCUTANEOUS CRICOTHYROIDOTOMY | Frederic J. Toye, M.D. | 1984-10-15 | 794 | 0 |
| K832498 | PERCUTANEOUS TRACHEOSTOMY DEVICE | Frederic J. Toye, M.D. | 1983-10-14 | 79 | 0 |
| K830509 | EMERGENCY TRACHEOSTOMY & CRICOTHYROIDO- | Frederic J. Toye, M.D. | 1983-03-29 | 40 | 0 |
| K821821 | PERCUTANEOUS TRACHEOSTOMY DEVICE | Frederic J. Toye, M.D. | 1982-07-19 | 27 | 0 |
| K801379 | CUFFED TRACHEA TUBE FOR USE W/PERTRACH | Frederic J. Toye, M.D. | 1980-09-09 | 90 | 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