Electrocore, Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Electrocore, Inc.” (first 2017, latest 2021), plus 1 De Novo decision, across 1 product code in 1 review panel. Median 510(k) review time under this name: 78 days. Since 2017 the median was 78 days, against 82 days for all cleared 510(k)s in the same product codes. 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 |
|---|---|---|
| 2017 | 1 | 27 |
| 2018 | 3 | 78 |
| 2019 | 0 | — |
| 2020 | 1 | 261 |
| 2021 | 2 | 78 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Electrocore, Inc. took a median 78 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 82 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| PKR | Non-Invasive Vagus Nerve Stimulator - Headache | 8 | 7 |
Review panels
- Neurology (8)
Most recent Electrocore, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K211856 | gammaCore Sapphire | PKR | 2021-09-10 | 86 |
| K203546 | gammaCore Sapphire | PKR | 2021-02-12 | 70 |
| K191830 | gammaCore Sapphire | PKR | 2020-03-26 | 261 |
| K182369 | gammaCore Sapphire | PKR | 2018-11-27 | 88 |
| K180538 | gammaCore Sapphire | PKR | 2018-03-30 | 30 |
| K173442 | gammaCore-S | PKR | 2018-01-23 | 78 |
| K171306 | gammaCore-S | PKR | 2017-05-30 | 27 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN150048 | De Novo | Non-Invasive Vagus Nerve Stimulator - Headache | 2017-04-14 |
Recalls
openFDA lists no recalls under a recalling firm named Electrocore, 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.
Device clinical trials
An industry sponsor named Electrocore, Inc. is the lead sponsor of 12 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT03716505: Non-invasive Vagus Nerve Stimulation for the Prevention of Migraines (Completed, started 2018-11-02)
- NCT02686034: RCT of Non-Invasive Vagus Nerve Stimulation (nVNS) With gammaCore®, for the Acute Treatment of Migraine Attacks (Completed, started 2016-01)
- NCT02378844: A Randomized, Sham-controlled Study of gammaCore ® (nVNS) for Prevention of Episodic Migraine (Completed, started 2015-06)
- NCT02388269: A Randomized, Single Centre, Double-blind, Parallel, Sham-controlled Pilot Study Using gammaCore®-G (Completed, started 2014-06)
- NCT01958125: A Randomized Multicentre Study for the Acute Relief of Episodic and Chronic Cluster Headache. (Completed, started 2013-08)
SEC filings
electroCore, Inc. (ECOR): EDGAR filings, CIK 1560258. An SEC registrant with the same name, matched by name only.
Frequently asked questions
How many FDA 510(k) clearances are listed under Electrocore, Inc.?
FDA lists 7 510(k) clearances under the applicant name “Electrocore, Inc.” (first 2017, latest 2021), plus 1 De Novo decision, across 1 product code 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 Electrocore, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Electrocore, Inc. is 78 days. Since 2017: 78 days, versus 82 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Electrocore, Inc.?
The most frequent FDA product codes under this applicant name are PKR (Non-Invasive Vagus Nerve Stimulator - Headache, 8).
Next steps
- See all 7 Electrocore, Inc. clearances with predicates and recalls
- Run predicate analysis for product code PKR, Electrocore, 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.