Not Cleared Direct

PCWP Analysis Software (DEN250057) - FDA 510(k) Clearance

DEN250057 · Cardiosense, Inc. · Cardiovascular device
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May 2026
Decision
186d
Days
-
Risk

DEN250057 is an FDA 510(k) submission (not cleared) for the PCWP Analysis Software.

Submitted by Cardiosense, Inc. (Chicago, US). The FDA issued a Not Cleared (DENG) decision on May 22, 2026 after a review of 186 days.

This device falls under the Cardiovascular FDA review panel. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. This submission did not achieve clearance, indicating the FDA determined the device lacked sufficient predicate equivalence under the Cardiovascular review framework.

View all Cardiosense, Inc. devices

Submission Details

510(k) Number DEN250057 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received November 17, 2025
Decision Date May 22, 2026
Days to Decision 186 days
Submission Type Direct
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
61d slower than avg
Panel avg: 125d · This submission: 186d
Pathway characteristics

Device Classification

Product Code SIF
Device Class -