FDA product code · Cardiovascular
Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)
3 FDA decisions since 2004. 17 recalls name this code, 8 of them Class I.
These devices are indicated for patients who have moderate to severe heart failure. These new devices use an additional lead to provide synchronized pacing of the heart, in addition to the regular features of a pacemaker. These products are sought for the treatment of patients who have moderate to severe heart failure.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of NKE 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 · NKE
22in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NKE
Too few NKE 510(k)s in any year since 2007 to give a median.
Recalls per year · NKE
5in 2025
Class I (8 since 2007) Class II/III not classified
Adverse event reports per year · NKE
1,939in 2025
MAUDE reports naming product code NKE, 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 | 19 | — | 0 | 37 |
| 2008 | 24 | — | 0 | 52 |
| 2009 | 22 | — | 0 | 81 |
| 2010 | 27 | — | 0 | 169 |
| 2011 | 29 | — | 0 | 196 |
| 2012 | 19 | — | 0 | 164 |
| 2013 | 44 | — | 0 | 207 |
| 2014 | 54 | — | 0 | 127 |
| 2015 | 58 | — | 1 | 356 |
| 2016 | 33 | — | 0 | 514 |
| 2017 | 48 | — | 7 | 607 |
| 2018 | 29 | — | 0 | 1,004 |
| 2019 | 29 | — | 0 | 794 |
| 2020 | 30 | — | 0 | 806 |
| 2021 | 26 | — | 0 | 1,177 |
| 2022 | 24 | — | 0 | 1,290 |
| 2023 | 27 | — | 0 | 1,469 |
| 2024 | 23 | — | 2 (2) | 1,518 |
| 2025 | 22 | — | 5 (5) | 1,939 |
| 2026 | 19 | — | 1 (1) | — |
Planning a device in NKE? 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