FDA product code · Neurology
Stimulator, Low Electric Field, Tumor Treatment
1 FDA decision since 2011. No recall names this code.
Intended to treat tumors by application of low electic fields and indicated for treatment of recurrent glioblastoma multiforme (gbm) in patients who have received maximum standard therapy with continued disease progress, as defined by tumor growth or decline in neurological status.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of NZK 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 · NZK
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NZK
Too few NZK 510(k)s in any year since 2007 to give a median.
Recalls per year · NZK
No recall names NZK since 2007.
Adverse event reports per year · NZK
240in 2025
MAUDE reports naming product code NZK, 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 | 1 | — | 0 | 0 |
| 2012 | 2 | — | 0 | 12 |
| 2013 | 4 | — | 0 | 22 |
| 2014 | 4 | — | 0 | 11 |
| 2015 | 3 | — | 0 | 23 |
| 2016 | 3 | — | 0 | 9 |
| 2017 | 1 | — | 0 | 12 |
| 2018 | 3 | — | 0 | 23 |
| 2019 | 2 | — | 0 | 21 |
| 2020 | 1 | — | 0 | 30 |
| 2021 | 4 | — | 0 | 32 |
| 2022 | 1 | — | 0 | 26 |
| 2023 | 1 | — | 0 | 29 |
| 2024 | 7 | — | 0 | 156 |
| 2025 | 4 | — | 0 | 240 |
| 2026 | 5 | — | 0 | — |
Planning a device in NZK? 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) Report