Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Tracor Instruments, Inc. — Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
20 daysmedian FDA review time
76 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K853245 | TRACOR MODEL RA600 MICROPROCESSOR AUDIOMETER | Tracor Instruments, Inc. | 1985-10-16 | 76 | 0 |
| K851392 | TRACOR 200 MICROPROCESSOR AUDIOMETER/TRACOR RA 200 | Tracor Instruments, Inc. | 1985-06-20 | 72 | 0 |
| K822414 | TRACOR RA400 AUDIOMETER | Tracor Instruments, Inc. | 1982-08-30 | 19 | 0 |
| K790903 | TRACOR MODEL RA-411 MICROPROCESSOR | Tracor Instruments, Inc. | 1979-05-31 | 20 | 0 |
| K781743 | RESPONSE SYSTEM, TN-3000 | Tracor Instruments, Inc. | 1978-12-01 | 42 | 0 |
| K781704 | STIMULATOR, TN-3001 SOMATOSENSORY | Tracor Instruments, Inc. | 1978-12-01 | 52 | 0 |
| K780749 | SPEECH AUDIOMETER RA 226 | Tracor Instruments, Inc. | 1978-05-16 | 12 | 0 |
| K780450 | TRACOR RA 410 AUDIOMETER | Tracor Instruments, Inc. | 1978-03-30 | 10 | 0 |
| K780474 | AUDIOMETER CALIBRATOR MODEL RA 310 | Tracor Instruments, Inc. | 1978-03-30 | 6 | 0 |
| K760859 | TRACOR MODEL RA 208 COMPLIANCE AUDIOM | Tracor Instruments, Inc. | 1976-10-29 | 11 | 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