De Novo · Granted
GrantedCaRi-Heart
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Caristo Diagnostics, Ltd. · SIU Predictive Indicator For Long-Term Cardiovascular Outcomes
Granted on Jul 28, 2026 as a new device type through De Novo after a 327-day review.
- Decided
- Jul 28, 2026
- Review
- 327 days
- Class
- Class II
- Product code
- SIU
- Recalls
- None
De Novo grants create a new device type without a predicate, so this family tree starts here.
Sources: FDA De Novo database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in SIU? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All SIU devicesSIU Predictive Indicator For Long-Term Cardiovascular Outcomes: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · SIU
1so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · SIU
Too few SIU 510(k)s in any year since 2007 to give a median.
Recalls per year · SIU
No recall names SIU since 2007.
Adverse event reports per year · SIU
No MAUDE report names SIU 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 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
CaRi-Heart is a software device used to produce analysis results to assist Healthcare Professionals in patient management. It helps operators assess vascular inflammation from coronary computed tomography angiography (CCTA) images and measure risk of cardiovascular mortality due to coronary inflammation and other clinical risk factors. CaRi-Heart and its analysis results are indicated for adults from 30 to 80 years old who have been referred for CCTA…
Read the full statement (128 words)
CaRi-Heart is a software device used to produce analysis results to assist Healthcare Professionals in patient management. It helps operators assess vascular inflammation from coronary computed tomography angiography (CCTA) images and measure risk of cardiovascular mortality due to coronary inflammation and other clinical risk factors.
CaRi-Heart and its analysis results are indicated for adults from 30 to 80 years old who have been referred for CCTA imaging.
CaRi-Heart is to be used by trained operators. CaRi-Heart analysis results are to be used by Healthcare Professionals.
CaRi-Heart analysis results should be reviewed with other clinical information which may include, but is not limited to: the patient's original CT images, clinical history, symptoms, clinical risk factors, results of other diagnostic tests, and the clinical judgement of appropriately qualified Healthcare Professionals.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN250042 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN250042: CaRi-Heart.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN250042
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Page last updated Nov 3, 2026