FDA product code · Cardiovascular
Tricuspid Valve Repair Device, Percutaneously Delivered
1 FDA decision since 2024. No recall names this code.
These devices are intended to repair heart valves by methods other than that used by the classified device (annuloplasty rings). They may be placed using non-traditional techniques or other novel methods for decreasing valvular regurgitation.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of NPS 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 · NPS
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NPS
Too few NPS 510(k)s in any year since 2007 to give a median.
Recalls per year · NPS
No recall names NPS since 2007.
Adverse event reports per year · NPS
917in 2025
MAUDE reports naming product code NPS, 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 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 9 | — | 0 | 546 |
| 2025 | 9 | — | 0 | 917 |
| 2026 | 6 | — | 0 | — |
Planning a device in NPS? 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