FDA product code · Cardiovascular
Cardiac Device Identifier
1 FDA decision since 2026. No recall names this code.
A cardiac device identifier is a noninvasive device that is intended to provide information about implanted cardiac devices. The device detects and matches telemetry based on manufacturer-specific wireless communication signals, including radiofrequency or inductive signals, to identify an implanted cardiac device, including manufacturer, model, or type. The device is not intended to deliver therapeutic stimulation…
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of SJJ 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 · SJJ
1so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · SJJ
Too few SJJ 510(k)s in any year since 2007 to give a median.
Recalls per year · SJJ
No recall names SJJ since 2007.
Adverse event reports per year · SJJ
No MAUDE report names SJJ since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
Planning a device in SJJ? 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