FDA product code · Cardiovascular
Pulse-Generator, Single Chamber, Sensor Driven, Implantable
2 FDA decisions since 1986. No recall names this code. The most-cited predicate is P970013, named by 1 later device.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of LWO 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 · LWO
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LWO
Too few LWO 510(k)s in any year since 2007 to give a median.
Recalls per year · LWO
No recall names LWO since 2007.
Adverse event reports per year · LWO
10in 2025
MAUDE reports naming product code LWO, 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 | 8 | — | 0 | 0 |
| 2008 | 10 | — | 0 | 1 |
| 2009 | 5 | — | 0 | 0 |
| 2010 | 7 | — | 0 | 0 |
| 2011 | 10 | — | 0 | 1 |
| 2012 | 1 | — | 0 | 2 |
| 2013 | 0 | — | 0 | 3 |
| 2014 | 0 | — | 0 | 3 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 1 | — | 0 | 1 |
| 2017 | 6 | — | 0 | 3 |
| 2018 | 5 | — | 0 | 1 |
| 2019 | 1 | — | 0 | 5 |
| 2020 | 3 | — | 0 | 16 |
| 2021 | 4 | — | 0 | 12 |
| 2022 | 3 | — | 0 | 5 |
| 2023 | 2 | — | 0 | 16 |
| 2024 | 1 | — | 0 | 10 |
| 2025 | 5 | — | 0 | 10 |
| 2026 | 2 | — | 0 | — |
Planning a device in LWO? 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