FDA product code · Obstetrics and gynecology
Automated Cryopreservation Storage System
FDA lists QUJ as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 884.9 applies, such as a new intended use or a different fundamental technology. 1 FDA decision since 2022. 510(k) reviews decided 2021–2025 took a median of 205 days (half between 205 and 205). No recall names this code.
To provide an automated liquid nitrogen storage system for oocytes, embryos, and sperm.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of QUJ 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 · QUJ
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · QUJ
Too few QUJ 510(k)s in any year since 2007 to give a median.
Recalls per year · QUJ
No recall names QUJ since 2007.
Adverse event reports per year · QUJ
No MAUDE report names QUJ since 2007.
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 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
Planning a device in QUJ? 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 884.6120.