FDA product code · Microbiology
Direct Blood Bacterial Nucleic Acid Detection System
2 FDA decisions since 2018. 510(k) reviews decided 2021–2025 took a median of 133 days (half between 133 and 133). No recall names this code. The most-cited predicate is K172708, named by 1 later device.
Amplification, detection and identification of microbial pathogens directly from whole blood specimens
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of QBX 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 · QBX
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · QBX
Too few QBX 510(k)s in any year since 2007 to give a median.
Recalls per year · QBX
No recall names QBX since 2007.
Adverse event reports per year · QBX
31in 2024
MAUDE reports naming product code QBX, 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 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 7 |
| 2023 | 0 | — | 0 | 17 |
| 2024 | 1 | — | 0 | 31 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
Planning a device in QBX? 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 866.3960.