FDA product code · Cardiovascular
Defibrillator, Implantable, Dual-Chamber
3 FDA decisions since 1999. 6 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 MRM 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 · MRM
23in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MRM
Too few MRM 510(k)s in any year since 2007 to give a median.
Recalls per year · MRM
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MRM
451in 2025
MAUDE reports naming product code MRM, 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 | 12 | — | 1 | 34 |
| 2008 | 32 | — | 0 | 77 |
| 2009 | 20 | — | 0 | 243 |
| 2010 | 28 | — | 0 | 581 |
| 2011 | 16 | — | 1 | 458 |
| 2012 | 19 | — | 0 | 427 |
| 2013 | 24 | — | 1 | 397 |
| 2014 | 20 | — | 0 | 320 |
| 2015 | 18 | — | 0 | 293 |
| 2016 | 20 | — | 0 | 384 |
| 2017 | 24 | — | 0 | 415 |
| 2018 | 19 | — | 0 | 372 |
| 2019 | 20 | — | 0 | 345 |
| 2020 | 23 | — | 0 | 316 |
| 2021 | 18 | — | 0 | 575 |
| 2022 | 9 | — | 0 | 505 |
| 2023 | 20 | — | 0 | 551 |
| 2024 | 19 | — | 0 | 514 |
| 2025 | 23 | — | 0 | 451 |
| 2026 | 25 | — | 0 | — |
Planning a device in MRM? 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