FDA product code · Neurology
Stimulator, Electrical, Implanted, For Parkinsonian Tremor
2 FDA decisions since 1997. 26 recalls name this code, 0 of them Class I.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of MHY 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 · MHY
44in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MHY
Too few MHY 510(k)s in any year since 2007 to give a median.
Recalls per year · MHY
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MHY
3,373in 2025
MAUDE reports naming product code MHY, 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 | 3 | — | 3 | 710 |
| 2008 | 7 | — | 4 | 1,450 |
| 2009 | 18 | — | 0 | 1,314 |
| 2010 | 28 | — | 0 | 1,532 |
| 2011 | 31 | — | 0 | 1,597 |
| 2012 | 25 | — | 2 | 2,382 |
| 2013 | 23 | — | 1 | 2,845 |
| 2014 | 25 | — | 0 | 2,621 |
| 2015 | 18 | — | 0 | 3,088 |
| 2016 | 37 | — | 1 | 3,559 |
| 2017 | 45 | — | 1 | 3,561 |
| 2018 | 36 | — | 1 | 4,494 |
| 2019 | 42 | — | 0 | 2,817 |
| 2020 | 37 | — | 1 | 2,673 |
| 2021 | 36 | — | 3 | 2,427 |
| 2022 | 34 | — | 1 | 2,257 |
| 2023 | 31 | — | 1 | 3,489 |
| 2024 | 47 | — | 1 | 4,386 |
| 2025 | 44 | — | 1 | 3,373 |
| 2026 | 29 | — | 2 | — |
Planning a device in MHY? 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