510(k) · Cleared
ClearedCorVista System® with PCWP Add-On
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Analytics For Life, Inc. · DQK Computer, Diagnostic, Programmable
Cleared on Jul 26, 2026 as substantially equivalent to K233666 (Analytics For Life, Inc., 2024) after a 251-day review. Its family tree reaches back 3 generations to 2023.
- Decided
- Jul 26, 2026
- Review
- 251 days
- Class
- Class II
- Product code
- DQK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to DEN230003 (2023). No later device cites it as a predicate yet.
- Root · 3 generations backDEN230003 Viz HCMViz. Ai, Inc. · 2023
- 2 generations backK232686 CorVista® SystemCorvista Health, Inc. · 2023
- 1 generation backK233666 CorVista System with PH Add-OnAnalytics For Life, Inc. · 2024
- This deviceK253576 CorVista System® with PCWP Add-OnAnalytics For Life, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
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 DQK? 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 DQK device
- #1 K213682 HemoSphere Advanced Monitor, HemoSphere…score 26.6 · 28 generations · no Class I recall
- #2 Held for the reportin the report
- #3 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 |
|---|---|---|---|
| * | K233666 | CorVista System with PH Add-OnSummary page 5…achine learning-based notification software Classification Name: N/A Regulation Number: 870.2380 Product Codes: QXO Legally Marketed Predicate Devices Predicate #: K233666 Predicate Trade Name: CorVista System with PH Add-on Product Code: SAT Device Description Summary The CorVista System is a n… | 2024 |
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.
What does this lineage say?
- The line of descent spans 3 years and passes through 3 companies; a new generation was cleared every 7 months on median.
- None of the 3 ancestors has a recall.
- 1 other device also cites its predicate K233666.
How does its category compare?
All DQK devicesDQK Computer, Diagnostic, Programmable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · DQK
23so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · DQK
95in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQK
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DQK
433in 2025
MAUDE reports naming product code DQK, 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 | 13 | 83 | 4 | 18 |
| 2008 | 4 | 70 | 1 | 34 |
| 2009 | 12 | 93 | 2 | 40 |
| 2010 | 9 | 64 | 3 | 49 |
| 2011 | 12 | 69 | 2 | 55 |
| 2012 | 7 | 74 | 3 | 129 |
| 2013 | 13 | 68 | 1 | 180 |
| 2014 | 9 | 90 | 4 | 115 |
| 2015 | 7 | 125 | 2 | 131 |
| 2016 | 15 | 190 | 0 | 340 |
| 2017 | 7 | 146 | 2 | 252 |
| 2018 | 14 | 150 | 6 | 261 |
| 2019 | 15 | 113 | 1 | 218 |
| 2020 | 16 | 123 | 1 | 215 |
| 2021 | 16 | 132 | 1 | 351 |
| 2022 | 19 | 136 | 2 | 319 |
| 2023 | 21 | 133 | 2 | 340 |
| 2024 | 13 | 100 | 24 | 557 |
| 2025 | 22 | 95 | 1 | 433 |
| 2026 | 23 | 151 | 2 | — |
What is it indicated for?
The CorVista System with PCWP Add-on analyzes sensor-acquired physiological signals of patients presenting with cardiovascular symptoms (such as chest pain, dyspnea, fatigue) with no history of elevated PCWP or prior right heart catheterization. It provides a binary output and indicates the likelihood of elevated PCWP defined as >18 mmHg as measured by right heart catheterization (RHC). 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/K253576 · printed Nov 6, 2026
Cite this page
510(k) Report. “K253576: CorVista System® with PCWP 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/K253576
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026