510(k) Report

FDA applicant

Electrocore, LLC

Basking Ridge, NJ8 decisions2017–20210 recalls

FDA records 8 decisions for Electrocore, LLC (Basking Ridge, NJ) from 2017 to 2021: 7 510(k) clearances and 1 De Novo grant. All are in product code PKR (Non-Invasive Vagus Nerve Stimulator - Headache). Since 2016 its 510(k)s took a median of 78 days from receipt to decision, against 78 for FDA’s reviews in the same codes and years. Its devices cite 7 predicates, 6 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Electrocore, Inc.”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, neurology panel, where it files most

How often FDA has decided Electrocore, LLC’s devices, and how often a recall has named them.

FDA decisions per year

2in 2021

2017: 22018: 32020: 12021: 2
2017high 3 (2018) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2017.

FIG. 1 — Electrocore, LLC by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Electrocore, LLC’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • PKRNon-Invasive Vagus Nerve Stimulator - Headache8decisions

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 78 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 78 days; 1 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 7 predicates; 6 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 7 times; 6 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K171306gammaCore-SElectrocore, LLC · 20172cite it
  • K180538gammaCore SapphireElectrocore, LLC · 20181cites it
  • DEN150048gammaCore Non-invasive Vagus Nerve StimulatorElectrocore, LLC · 20171cites it
  • K182369gammaCore SapphireElectrocore, Inc. · 20181cites it
  • K191830gammaCore SapphireElectrocore, Inc. · 20201cites it
  • K203546gammaCore SapphireElectrocore, Inc. · 20211cites it

What has FDA decided for it lately?

  • K211856gammaCore SapphireElectrocore, Inc. · 2021
  • K203546gammaCore SapphireElectrocore, Inc. · 2021
  • K191830gammaCore SapphireElectrocore, Inc. · 2020
  • K182369gammaCore SapphireElectrocore, Inc. · 2018
  • K180538gammaCore SapphireElectrocore, LLC · 2018
  • K173442gammaCore-SElectrocore, LLC · 2018
  • K171306gammaCore-SElectrocore, LLC · 2017
  • DEN150048gammaCore Non-invasive Vagus Nerve StimulatorElectrocore, LLC · 2017

All 4 as Electrocore, LLC →All 4 as Electrocore, Inc. →