FDA product code · Cardiovascular
Mitral Valve Repair Devices
2 FDA decisions since 2013. 4 recalls name this code, 1 of them Class I.
To repair the mitral valve by coapting the valve leaflets to prevent mitral regurgitation. These devices are different from the classified device (annuloplasty rings) in that a cardiotomy is not required to place them, some of them are placed percutaneously, and they definitely are not rings that are sewn on to the valve annulus.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of NKM 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 · NKM
16in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NKM
Too few NKM 510(k)s in any year since 2007 to give a median.
Recalls per year · NKM
3in 2022
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · NKM
2,833in 2025
MAUDE reports naming product code NKM, 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 | 1 |
| 2013 | 1 | — | 0 | 40 |
| 2014 | 8 | — | 0 | 484 |
| 2015 | 5 | — | 0 | 544 |
| 2016 | 6 | — | 1 (1) | 826 |
| 2017 | 4 | — | 0 | 1,138 |
| 2018 | 3 | — | 0 | 1,668 |
| 2019 | 9 | — | 0 | 2,278 |
| 2020 | 1 | — | 0 | 2,724 |
| 2021 | 5 | — | 0 | 2,346 |
| 2022 | 12 | — | 3 | 2,584 |
| 2023 | 20 | — | 0 | 2,475 |
| 2024 | 15 | — | 0 | 2,562 |
| 2025 | 16 | — | 0 | 2,833 |
| 2026 | 11 | — | 0 | — |
Planning a device in NKM? 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