FDA product code · Cardiovascular
Analyzer, Pacemaker Generator Function
30 FDA decisions since 1976. No recall names this code. The most-cited predicate is K903966, named by 2 later devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of DTC 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 · DTC
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · DTC
Too few DTC 510(k)s in any year since 2007 to give a median.
Recalls per year · DTC
No recall names DTC since 2007.
Adverse event reports per year · DTC
1,159in 2025
MAUDE reports naming product code DTC, 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 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 2 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 34 |
| 2018 | 0 | — | 0 | 22 |
| 2019 | 0 | — | 0 | 138 |
| 2020 | 0 | — | 0 | 189 |
| 2021 | 0 | — | 0 | 636 |
| 2022 | 0 | — | 0 | 218 |
| 2023 | 0 | — | 0 | 215 |
| 2024 | 0 | — | 0 | 1,076 |
| 2025 | 0 | — | 0 | 1,159 |
| 2026 | 0 | — | 0 | — |
Planning a device in DTC? 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