FDA product code PKR: Non-Invasive Vagus Nerve Stimulator - Headache
PKR is the FDA product code for non-invasive vagus nerve stimulator - headache. It is a Class II device, regulated under 21 CFR 882.5892 and reviewed by the Neurology panel. FDA has cleared 8 510(k) submissions under PKR, from 3 different applicants. The average 510(k) review took 96 days (median 82). 1 De Novo request was granted under it.
Definition
The device intended for non-invasive vagus nerve stimulation (nVNS) on the side of the neck to treat cluster headache and to reduce the frequency of cluster headache attacks.
Classification
| Field | Value |
|---|---|
| Device name | Non-Invasive Vagus Nerve Stimulator - Headache |
| Device class | Class II |
| Regulation | 21 CFR 882.5892 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
510(k) clearances per year for PKR
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 2 | 80 |
| 2018 | 3 | 65 |
| 2020 | 1 | 261 |
| 2021 | 2 | 78 |
Compare with all 510(k) review times · Search every PKR clearance
Top PKR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Electrocore, Inc. | 4 | 2021-09-10 |
| Electrocore, LLC | 3 | 2018-03-30 |
| Eletrocore, LLC | 1 | 2017-12-07 |
Most recent PKR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K211856 | Electrocore, Inc. | gammaCore Sapphire | 2021-09-10 | 86 |
| K203546 | Electrocore, Inc. | gammaCore Sapphire | 2021-02-12 | 70 |
| K191830 | Electrocore, Inc. | gammaCore Sapphire | 2020-03-26 | 261 |
| K182369 | Electrocore, Inc. | gammaCore Sapphire | 2018-11-27 | 88 |
| K180538 | Electrocore, LLC | gammaCore Sapphire | 2018-03-30 | 30 |
Recalls for PKR devices
openFDA lists no recalls for product code PKR.
Frequently asked questions
What is FDA product code PKR?
PKR is the FDA product code for non-invasive vagus nerve stimulator - headache. It is a Class II device, regulated under 21 CFR 882.5892 and reviewed by the Neurology panel.
What device class is PKR?
Class II, regulation 21 CFR 882.5892. Typical premarket route: 510(k).
How long does a 510(k) take for product code PKR?
Across 8 cleared submissions the average was 96 days from receipt to decision (median 82).
Which companies have the most PKR clearances?
Electrocore, Inc. (4); Electrocore, LLC (3); Eletrocore, LLC (1).
Next steps
- Run an FDA pathway report with predicate devices for product code PKR
- Run a recall and safety report across every PKR manufacturer
- Watch product code PKR for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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