FDA product code · Cardiovascular
Wearable Automated External Defibrillator
3 FDA decisions since 2001. 5 recalls name this code, 0 of them Class I.
The device is an automatic external defibrillator which monitors and treats a patient for ventricular defibrillation. Device is intended to be worn in home or in hospital settings as prescribed and overseen by a physician.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of MVK 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 · MVK
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MVK
Too few MVK 510(k)s in any year since 2007 to give a median.
Recalls per year · MVK
1in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MVK
12,137in 2025
MAUDE reports naming product code MVK, 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 | 2 | — | 2 | 446 |
| 2008 | 2 | — | 1 | 690 |
| 2009 | 6 | — | 0 | 946 |
| 2010 | 4 | — | 1 | 1,363 |
| 2011 | 8 | — | 0 | 1,975 |
| 2012 | 10 | — | 0 | 3,375 |
| 2013 | 6 | — | 0 | 3,805 |
| 2014 | 7 | — | 0 | 5,086 |
| 2015 | 15 | — | 0 | 8,415 |
| 2016 | 15 | — | 0 | 9,463 |
| 2017 | 12 | — | 1 | 10,853 |
| 2018 | 8 | — | 0 | 9,941 |
| 2019 | 22 | — | 0 | 9,894 |
| 2020 | 14 | — | 0 | 11,904 |
| 2021 | 14 | — | 0 | 12,466 |
| 2022 | 6 | — | 0 | 12,667 |
| 2023 | 17 | — | 0 | 12,988 |
| 2024 | 21 | — | 0 | 12,585 |
| 2025 | 15 | — | 0 | 12,137 |
| 2026 | 13 | — | 0 | — |
Planning a device in MVK? 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