Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Electrocore, LLC — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K180538 | gammaCore Sapphire | Electrocore, LLC | 2018-03-30 | 30 | 0 |
| K173442 | gammaCore-S | Electrocore, LLC | 2018-01-23 | 78 | 0 |
| K171306 | gammaCore-S | Electrocore, LLC | 2017-05-30 | 27 | 0 |
| DEN150048 | gammaCore Non-invasive Vagus Nerve Stimulator | Electrocore, LLC | 2017-04-14 | 546 | 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