Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
PKR — Predicate Candidate Screening
9 FDA 510(k) clearances under this product code; the 50 most recent screened below.
86 daysmedian FDA review time
546 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K211856 | gammaCore Sapphire | Electrocore, Inc. | 2021-09-10 | 86 | 0 |
| K203546 | gammaCore Sapphire | Electrocore, Inc. | 2021-02-12 | 70 | 0 |
| K191830 | gammaCore Sapphire | Electrocore, Inc. | 2020-03-26 | 261 | 0 |
| K182369 | gammaCore Sapphire | Electrocore, Inc. | 2018-11-27 | 88 | 0 |
| K180538 | gammaCore Sapphire | Electrocore, LLC | 2018-03-30 | 30 | 0 |
| K173442 | gammaCore-S | Electrocore, LLC | 2018-01-23 | 78 | 0 |
| K172270 | gammaCore-2 | Eletrocore, LLC | 2017-12-07 | 132 | 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