# K253576: CorVista System® with PCWP Add-On

- Pathway: 510(k) (Traditional)
- Applicant: Analytics For Life, Inc.
- Decided: Jul 26, 2026 after 251 days
- Product code: DQK (Computer, Diagnostic, Programmable)
- Device class: 2
- Regulation: 21 CFR 870.1425
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to DEN230003 (2023). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K233666: CorVista System with PH Add-On, Analytics For Life, Inc. (2024) Summary page 5.

## Indications for use
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.

Source page: https://510kreport.com/device/K253576
Methodology: https://510kreport.com/methodology