FDA product code · Gastroenterology and urology
Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation
2 FDA decisions since 2021. 1 recall names this code; it is not Class I.
The device is intended for machine preservation of donor livers prior to transplantation.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of QQK 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 · QQK
17in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QQK
Too few QQK 510(k)s in any year since 2007 to give a median.
Recalls per year · QQK
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · QQK
167in 2025
MAUDE reports naming product code QQK, 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 | 2 | — | 0 | 0 |
| 2022 | 4 | — | 0 | 0 |
| 2023 | 10 | — | 0 | 0 |
| 2024 | 10 | — | 1 | 139 |
| 2025 | 17 | — | 0 | 167 |
| 2026 | 11 | — | 0 | — |
Planning a device in QQK? 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