Tracor Northern, Inc.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Tracor Northern, Inc.” (first 1981, latest 1988), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 95 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
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 |
|---|---|---|---|
| GWF | Stimulator, Electrical, Evoked Response | 6 | 6 |
| GWE | Stimulator, Photic, Evoked Response | 2 | 2 |
| OLT | Non-Normalizing Quantitative Electroencephalograph Software | 2 | 2 |
Review panels
- Neurology (10)
Most recent Tracor Northern, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K883340 | NEURAL MAGNETIC STIMULATOR, THE D190 | GWF | 1988-12-29 | 142 |
| K874733 | GUARDIAN, EEG BRAIN MONITORING SYSTEM | OLT | 1988-02-29 | 103 |
| K860968 | TM-3400, NOMAD (MODIFIED) | GWF | 1986-08-18 | 160 |
| K860903 | TM-3600 A NEURODIAGNOSTIC SYSTEM | GWF | 1986-06-05 | 87 |
| K852587 | CDSA(COLOR DENSITY, SPECTRAL ARRRAY) | OLT | 1985-08-16 | 59 |
| K850109 | NOMAD TM-3400 | GWF | 1985-06-04 | 141 |
| K842964 | PHOTIC STIMULATOR TM-3030-70 | GWE | 1984-12-28 | 154 |
| K832084 | EVOKED 3500 POTENTIAL SYSTEM | GWE | 1983-08-16 | 49 |
| K822396 | THE 3500 | GWF | 1982-09-24 | 45 |
| K810560 | TN-3000 EVOKED RESPONSE SYSTEM | GWF | 1981-03-17 | 14 |
Recalls
openFDA lists no recalls under a recalling firm named Tracor Northern, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Tracor Instruments, Inc. (10 510(k)s)
- Tracor Instruments Austin, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Tracor Northern, Inc.?
FDA lists 10 510(k) clearances under the applicant name “Tracor Northern, Inc.” (first 1981, latest 1988), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Tracor Northern, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Tracor Northern, Inc. is 95 days.
Which FDA product codes appear under Tracor Northern, Inc.?
The most frequent FDA product codes under this applicant name are GWF (Stimulator, Electrical, Evoked Response, 6); GWE (Stimulator, Photic, Evoked Response, 2); OLT (Non-Normalizing Quantitative Electroencephalograph Software, 2).
Next steps
- See all 10 Tracor Northern, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GWF, Tracor Northern, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.