Cleared Traditional

K253576 - CorVista System® with PCWP Add-On

K253576 is an FDA 510(k) clearance for CorVista System with PCWP Add-On, manufactured by Analytics For Life, Inc.. The device is a Class 2 Cardiovascular device with product code DQK cleared through the Traditional 510(k) pathway after a 251-day FDA review.

K253576 · Analytics For Life, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2026
Decision
251d
Days
Class 2
Risk

K253576 is an FDA 510(k) clearance for the CorVista System® with PCWP Add-On. Classified as Computer, Diagnostic, Programmable (product code DQK), Class II - Special Controls.

Submitted by Analytics For Life, Inc. (Bethesda, US). The FDA issued a Cleared decision on July 26, 2026 after a review of 251 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1425 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Analytics For Life, Inc. devices

FDA 510(k) Submission Details - K253576

510(k) Number K253576 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 2025
Decision Date July 26, 2026
Days to Decision 251 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
126d slower than avg
Panel avg: 125d · This submission: 251d
Pathway characteristics
Predicate-based equivalence.

DQK Device Classification - Class 2, Special Controls

Product Code DQK Computer, Diagnostic, Programmable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1425
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Cardiovascular devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT03864081 Unknown Interventional Industry-sponsored

Non-invasive Point-of-care Diagnosis Using Machine Learning and Signal Analytics to Transform Early Detection of Heart Disease

Non-Invasive Point-of-care Diagnosis Using Machine Learning and Signal Analytics to Transform Early Detection of Heart Disease

2500
Patients (est.)
1
Site
Diagnostic
Purpose
Open label
Masking
Condition studied Coronary Artery Disease
Study design Single group
Eligibility All sexes · 21 Years+
Principal investigator William E Sanders, Jr., MD JD LLM MBA FHRS
Sponsor Analytics For Life (industry)
Started 2018-12-10 → Primary completion 2022-07-01
Primary outcome
Phase Signal Recorder Procedure
View full study on ClinicalTrials.gov

Regulatory Peers - DQK Computer, Diagnostic, Programmable

All 395
Devices cleared under the same product code (DQK) and FDA review panel - the closest regulatory comparables to K253576.
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ILR ECG Analyzer (IM007)
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