FDA product code · Cardiovascular
Heart-Valve, Non-Allograft Tissue
12 FDA decisions since 1979. 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 LWR 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 · LWR
27in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LWR
Too few LWR 510(k)s in any year since 2007 to give a median.
Recalls per year · LWR
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LWR
1,866in 2025
MAUDE reports naming product code LWR, 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 | 703 |
| 2008 | 7 | — | 0 | 1,552 |
| 2009 | 15 | — | 0 | 376 |
| 2010 | 17 | — | 0 | 279 |
| 2011 | 25 | — | 0 | 258 |
| 2012 | 18 | — | 0 | 718 |
| 2013 | 31 | — | 0 | 326 |
| 2014 | 27 | — | 1 | 365 |
| 2015 | 14 | — | 0 | 525 |
| 2016 | 27 | — | 1 | 736 |
| 2017 | 54 | — | 0 | 1,367 |
| 2018 | 64 | — | 0 | 1,593 |
| 2019 | 50 | — | 0 | 1,855 |
| 2020 | 32 | — | 0 | 1,437 |
| 2021 | 18 | — | 0 | 1,550 |
| 2022 | 37 | — | 0 | 1,084 |
| 2023 | 26 | — | 0 | 1,592 |
| 2024 | 27 | — | 0 | 1,829 |
| 2025 | 27 | — | 0 | 1,866 |
| 2026 | 19 | — | 0 | — |
Planning a device in LWR? 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