Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Electrical Geodesics, Inc. — Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K131882 | GEODESICEEG SYSTEM 400 SERIES (GES 400) | Electrical Geodesics, Inc. | 2014-02-12 | 232 | 1 |
| K112353 | GEODESIC EEG MOBILE 100 (GEM 100) | Electrical Geodesics, Inc. | 2012-02-17 | 185 | 0 |
| K092844 | GEOSOURCE | Electrical Geodesics, Inc. | 2010-12-21 | 462 | 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