FDA product code · Cardiovascular
Blood Pump For Ecmo, Long-Term (> 6 Hours) Use
8 FDA decisions since 2021. 510(k) reviews decided 2021–2025 took a median of 168 days (half between 102 and 207). 1 recall names this code; it is not Class I. The most-cited predicate is K202751, named by 2 later devices.
A blood pump for long-term circulatory support is a device intended for use as part of an extracorporeal circuit intended to provide assisted extracorporeal circulation and physiologic gas exchange of the patient's blood in patients with acute respiratory failure or acute cardiopulmonary failure where other available treatment options have failed and continued clinical deterioration is expected or the risk of death…
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of QNR 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 · QNR
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QNR
Too few QNR 510(k)s in any year since 2007 to give a median.
Recalls per year · QNR
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · QNR
187in 2025
MAUDE reports naming product code QNR, 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 | 1 | — | 0 | 1 |
| 2022 | 2 | — | 0 | 0 |
| 2023 | 2 | — | 0 | 5 |
| 2024 | 2 | — | 0 | 135 |
| 2025 | 1 | — | 1 | 187 |
| 2026 | 0 | — | 0 | — |
Planning a device in QNR? 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 870.4100.