FDA product code · Cardiovascular
Adjunctive Predictive Cardiovascular Indicator
5 FDA decisions since 2018. 510(k) reviews decided 2021–2025 took a median of 265 days (half between 208 and 268). No recall names this code. The most-cited predicate is DEN160044, named by 5 later devices.
The adjunctive predictive cardiovascular indicator is a prescription device that uses software algorithms to analyze cardiovascular vital signs and predict future cardiovascular status or events. This device is intended for adjunctive use with other physical vital sign parameters and patient information and is not intended to independently direct therapy.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of QAQ 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 · QAQ
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QAQ
Too few QAQ 510(k)s in any year since 2007 to give a median.
Recalls per year · QAQ
No recall names QAQ since 2007.
Adverse event reports per year · QAQ
14in 2025
MAUDE reports naming product code QAQ, 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 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 1 | — | 0 | 8 |
| 2024 | 0 | — | 0 | 5 |
| 2025 | 1 | — | 0 | 14 |
| 2026 | 0 | — | 0 | — |
Planning a device in QAQ? 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 870.2210.