FDA product code · Cardiovascular
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
4 FDA decisions since 2002. 61 recalls name this code, 6 of them Class I. The most-cited predicate is P030054, named by 4 later devices.
These devices will be indicated for patients needing an ICD who also have moderate to severe heart failure and are indicated for cardiac resynchronization therapy.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of NIK 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 · NIK
56in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NIK
Too few NIK 510(k)s in any year since 2007 to give a median.
Recalls per year · NIK
1in 2022
Class I (6 since 2007) Class II/III not classified
Adverse event reports per year · NIK
10,855in 2025
MAUDE reports naming product code NIK, 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 | 53 | — | 9 | 924 |
| 2008 | 62 | — | 1 | 3,021 |
| 2009 | 43 | — | 2 | 4,177 |
| 2010 | 51 | — | 7 | 5,668 |
| 2011 | 50 | — | 0 | 5,944 |
| 2012 | 83 | — | 2 | 5,582 |
| 2013 | 50 | — | 0 | 7,373 |
| 2014 | 76 | — | 0 | 10,731 |
| 2015 | 49 | — | 0 | 7,828 |
| 2016 | 109 | — | 2 (1) | 13,255 |
| 2017 | 112 | — | 9 (5) | 16,265 |
| 2018 | 91 | — | 0 | 8,348 |
| 2019 | 62 | — | 0 | 7,266 |
| 2020 | 75 | — | 3 | 9,609 |
| 2021 | 67 | — | 0 | 10,134 |
| 2022 | 62 | — | 1 | 10,646 |
| 2023 | 58 | — | 0 | 11,897 |
| 2024 | 56 | — | 0 | 11,697 |
| 2025 | 56 | — | 0 | 10,855 |
| 2026 | 44 | — | 0 | — |
Planning a device in NIK? 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