FDA product code · Neurology
Non-Invasive Vagus Nerve Stimulator - Headache
9 FDA decisions since 2017. 510(k) reviews decided 2021–2025 took a median of 78 days (half between 74 and 82). No recall names this code. The most-cited predicate is K171306, named by 2 later devices.
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.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of PKR at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.
FDA decisions per year · PKR
2in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · PKR
78in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PKR
No recall names PKR since 2007.
Adverse event reports per year · PKR
1in 2018
MAUDE reports naming product code PKR, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 3 | — | 0 | 0 |
| 2018 | 3 | 78 | 0 | 1 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 2 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
Planning a device in PKR? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportRelated product codes
Other codes under 21 CFR 882.5892.