Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Tracor Northern, Inc. — Predicate Candidate Screening

10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

103 daysmedian FDA review time
160 days90th percentile
10clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K883340NEURAL MAGNETIC STIMULATOR, THE D190Tracor Northern, Inc.1988-12-291420
K874733GUARDIAN, EEG BRAIN MONITORING SYSTEMTracor Northern, Inc.1988-02-291030
K860968TM-3400, NOMAD (MODIFIED)Tracor Northern, Inc.1986-08-181600
K860903TM-3600 A NEURODIAGNOSTIC SYSTEMTracor Northern, Inc.1986-06-05870
K852587CDSA(COLOR DENSITY, SPECTRAL ARRRAY)Tracor Northern, Inc.1985-08-16590
K850109NOMAD TM-3400Tracor Northern, Inc.1985-06-041410
K842964PHOTIC STIMULATOR TM-3030-70Tracor Northern, Inc.1984-12-281540
K832084EVOKED 3500 POTENTIAL SYSTEMTracor Northern, Inc.1983-08-16490
K822396THE 3500Tracor Northern, Inc.1982-09-24450
K810560TN-3000 EVOKED RESPONSE SYSTEMTracor Northern, Inc.1981-03-17140

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