FDA product code · Cardiovascular
Leadless Pacemaker
2 FDA decisions since 2016. 2 recalls name this code, 0 of them Class I.
To treat bradycardia (slow heartbeats) with right atrial and/or right ventricular pacing therapy as necessary.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of PNJ 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 · PNJ
33in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PNJ
Too few PNJ 510(k)s in any year since 2007 to give a median.
Recalls per year · PNJ
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PNJ
4,379in 2025
MAUDE reports naming product code PNJ, 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 | 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 | 12 | — | 0 | 84 |
| 2017 | 17 | — | 0 | 290 |
| 2018 | 18 | — | 0 | 656 |
| 2019 | 15 | — | 0 | 837 |
| 2020 | 27 | — | 0 | 1,148 |
| 2021 | 37 | — | 0 | 1,479 |
| 2022 | 36 | — | 0 | 1,712 |
| 2023 | 22 | — | 0 | 2,626 |
| 2024 | 28 | — | 1 | 3,392 |
| 2025 | 33 | — | 0 | 4,379 |
| 2026 | 21 | — | 1 | — |
Planning a device in PNJ? 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) ReportRelated product codes
Other codes under 21 CFR 870.3610.