510(k) · Cleared
ClearedCorVista System with PH Add-On
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Analytics For Life, Inc. · SAT Pulmonary Hypertension Machine Learning-Based Notification Software
Cleared on Apr 5, 2024 as substantially equivalent to K232686 (Corvista Health, Inc., 2023) after a 142-day review. Its family tree reaches back 2 generations to 2023. 2 later devices descend from it.
- Decided
- Apr 5, 2024
- Review
- 142 days
- Class
- Class II
- Product code
- SAT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN230003 (2023). 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backDEN230003 Viz HCMViz. Ai, Inc. · 2023
- 1 generation backK232686 CorVista® SystemCorvista Health, Inc. · 2023
- This deviceK233666 CorVista System with PH Add-OnAnalytics For Life, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK253699 Tempus ECG-PHTempus AI, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK253576 CorVista System® with PCWP Add-OnAnalytics For Life, Inc. · 2026
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | DEN230003 | Viz HCM | Viz. Ai, Inc. | 2023 | — |
| −1 | K232686 | CorVista® System | Corvista Health, Inc. | 2023 | — |
| 0 (this device) | K233666 | CorVista System with PH Add-On | Analytics For Life, Inc. | 2024 | — |
| +1 | K253699 | Tempus ECG-PH | Tempus AI, Inc. | 2026 | — |
| +1 | K253576 | CorVista System® with PCWP Add-On | Analytics For Life, Inc. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 2 | 0 |
Sources: FDA 510(k) 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 SAT? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new SAT device
- #1 K252360 ECG-AI Pulmonary Hypertension (PH) 12-Lead…score 14.7 · 3 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K232686 | CorVista® SystemSummary page 5…CorVista® System 510(k) Submitter / Holder Analytics for Life, Inc. (formerly CorVista Health, Inc.) 510(k) Number K232686 Regulation Number 21 CFR 870.2380 Classification Panel Cardiovascular Product Code… | 2023 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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.
What does this lineage say?
- The line of descent spans 1 year and passes through 3 companies; a new generation was cleared every 7 months on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K253699 (Tempus AI, Inc., 2026) has gone furthest, with 0 descendants of its own.
How does its category compare?
All SAT devicesSAT Pulmonary Hypertension Machine Learning-Based Notification Software: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · SAT
2so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · SAT
Too few SAT 510(k)s in any year since 2007 to give a median.
Recalls per year · SAT
No recall names SAT since 2007.
Adverse event reports per year · SAT
No MAUDE report names SAT 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 | 1 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The CorVista® System analyzes sensor-acquired physiological signals of patients presenting with cardiovascular symptoms (such as chest pain, dyspnea, fatigue) to provide a binary output indicating the likelihood of elevated mean pulmonary arterial pressure (mPAP), an indicator of pulmonary hypertension. The analysis is presented for interpretation by healthcare providers in conjunction with their clinical judgment, the patient's signs, symptoms, and clinical history as an aid in diagnosis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233666 · printed Nov 6, 2026
Cite this page
510(k) Report. “K233666: CorVista System with PH Add-On.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K233666
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026