Tracor Instruments, Inc.: FDA clearances and approvals
Tracor Instruments, Inc. has 10 FDA 510(k) clearances (first 1976, latest 1985), across 4 product codes in 2 review panels. Median 510(k) review time: 20 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| EWO | Audiometer | 7 | 7 |
| EWA | Set, Audiometer Calibration | 1 | 1 |
| GWF | Stimulator, Electrical, Evoked Response | 1 | 1 |
| GWL | Amplifier, Physiological Signal | 1 | 1 |
Review panels
- Ear, Nose and Throat (8)
- Neurology (2)
Most recent Tracor Instruments, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K853245 | TRACOR MODEL RA600 MICROPROCESSOR AUDIOMETER | EWO | 1985-10-16 | 76 |
| K851392 | TRACOR 200 MICROPROCESSOR AUDIOMETER/TRACOR RA 200 | EWO | 1985-06-20 | 72 |
| K822414 | TRACOR RA400 AUDIOMETER | EWO | 1982-08-30 | 19 |
| K790903 | TRACOR MODEL RA-411 MICROPROCESSOR | EWO | 1979-05-31 | 20 |
| K781743 | RESPONSE SYSTEM, TN-3000 | GWL | 1978-12-01 | 42 |
| K781704 | STIMULATOR, TN-3001 SOMATOSENSORY | GWF | 1978-12-01 | 52 |
| K780749 | SPEECH AUDIOMETER RA 226 | EWO | 1978-05-16 | 12 |
| K780474 | AUDIOMETER CALIBRATOR MODEL RA 310 | EWA | 1978-03-30 | 6 |
| K780450 | TRACOR RA 410 AUDIOMETER | EWO | 1978-03-30 | 10 |
| K760859 | TRACOR MODEL RA 208 COMPLIANCE AUDIOM | EWO | 1976-10-29 | 11 |
Recalls
openFDA lists no recalls under a recalling firm named Tracor Instruments, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Tracor Instruments, Inc. have?
Tracor Instruments, Inc. has 10 FDA 510(k) clearances (first 1976, latest 1985), across 4 product codes in 2 review panels.
How long does FDA take to clear Tracor Instruments, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Tracor Instruments, Inc.'s cleared 510(k)s is 20 days.
What devices does Tracor Instruments, Inc. make?
Its most frequent FDA product codes are EWO (Audiometer, 7); EWA (Set, Audiometer Calibration, 1); GWF (Stimulator, Electrical, Evoked Response, 1).
Has Tracor Instruments, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Tracor Instruments, Inc. Related entities may recall under other names.
Next steps
- See all 10 Tracor Instruments, Inc. clearances with predicates and recalls
- Run predicate analysis for product code EWO, Tracor Instruments, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.