FDA product code · Cardiovascular
Acute Coronary Syndrome Event Detector
1 FDA decision since 2018. No recall names this code.
Detect Acute Coronary Syndrome events and prompt the patient to seek medical attention.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of QBI 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 · QBI
3in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · QBI
Too few QBI 510(k)s in any year since 2007 to give a median.
Recalls per year · QBI
No recall names QBI since 2007.
Adverse event reports per year · QBI
35in 2025
MAUDE reports naming product code QBI, 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 | 2 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 3 | — | 0 | 0 |
| 2022 | 2 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 9 |
| 2024 | 3 | — | 0 | 12 |
| 2025 | 0 | — | 0 | 35 |
| 2026 | 0 | — | 0 | — |
Planning a device in QBI? 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