FDA product code · Anesthesiology
Valve, Pulmonary
2 FDA decisions since 2018. 3 recalls name this code, 0 of them Class I.
To improve lung function in patients with emphysema
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of NJK 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 · NJK
7in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · NJK
Too few NJK 510(k)s in any year since 2007 to give a median.
Recalls per year · NJK
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NJK
145in 2025
MAUDE reports naming product code NJK, 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 | 4 | — | 0 | 14 |
| 2019 | 14 | — | 0 | 215 |
| 2020 | 5 | — | 0 | 344 |
| 2021 | 2 | — | 1 | 405 |
| 2022 | 2 | — | 0 | 342 |
| 2023 | 3 | — | 1 | 266 |
| 2024 | 7 | — | 0 | 176 |
| 2025 | 0 | — | 0 | 145 |
| 2026 | 5 | — | 0 | — |
Planning a device in NJK? 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