FDA product code · Cardiovascular
Heart-Valve, Mechanical
9 FDA decisions since 1981. 2 recalls name this code, 0 of them Class I.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of LWQ 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 · LWQ
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LWQ
Too few LWQ 510(k)s in any year since 2007 to give a median.
Recalls per year · LWQ
1so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LWQ
330in 2025
MAUDE reports naming product code LWQ, 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 | 12 | — | 0 | 88 |
| 2008 | 15 | — | 0 | 90 |
| 2009 | 8 | — | 0 | 91 |
| 2010 | 6 | — | 0 | 119 |
| 2011 | 16 | — | 0 | 139 |
| 2012 | 21 | — | 0 | 122 |
| 2013 | 17 | — | 0 | 134 |
| 2014 | 11 | — | 0 | 134 |
| 2015 | 14 | — | 0 | 139 |
| 2016 | 13 | — | 0 | 202 |
| 2017 | 11 | — | 0 | 299 |
| 2018 | 8 | — | 0 | 434 |
| 2019 | 4 | — | 0 | 350 |
| 2020 | 6 | — | 0 | 372 |
| 2021 | 9 | — | 0 | 287 |
| 2022 | 8 | — | 0 | 297 |
| 2023 | 9 | — | 0 | 455 |
| 2024 | 6 | — | 0 | 404 |
| 2025 | 9 | — | 0 | 330 |
| 2026 | 5 | — | 1 | — |
Planning a device in LWQ? 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