FDA product code · Cardiovascular
Replacement Heart-Valve
8 FDA decisions since 1989. 2 recalls name this code, 0 of them Class I.
Call for pmas to be filed by 12/9/87 (52 fr 23137 (6/17/87))
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of DYE 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 · DYE
13in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DYE
Too few DYE 510(k)s in any year since 2007 to give a median.
Recalls per year · DYE
2in 2009
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DYE
3,106in 2025
MAUDE reports naming product code DYE, 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 | 28 | — | 0 | 19 |
| 2008 | 34 | — | 0 | 16 |
| 2009 | 31 | — | 2 | 910 |
| 2010 | 47 | — | 0 | 1,071 |
| 2011 | 22 | — | 0 | 1,221 |
| 2012 | 58 | — | 0 | 1,015 |
| 2013 | 66 | — | 0 | 1,219 |
| 2014 | 38 | — | 0 | 1,282 |
| 2015 | 13 | — | 0 | 1,242 |
| 2016 | 22 | — | 0 | 1,744 |
| 2017 | 34 | — | 0 | 2,284 |
| 2018 | 27 | — | 0 | 3,166 |
| 2019 | 16 | — | 0 | 2,820 |
| 2020 | 13 | — | 0 | 2,466 |
| 2021 | 7 | — | 0 | 2,833 |
| 2022 | 8 | — | 0 | 2,566 |
| 2023 | 11 | — | 0 | 3,489 |
| 2024 | 7 | — | 0 | 3,435 |
| 2025 | 13 | — | 0 | 3,106 |
| 2026 | 7 | — | 0 | — |
Planning a device in DYE? 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 870.3925.