Not Cleared Direct

DEN250042 - CaRi-Heart

DEN250042 · Caristo Diagnostics , Ltd. · Cardiovascular device
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Jul 2026
Decision
327d
Days
-
Risk

DEN250042 is an FDA 510(k) submission (not cleared) for the CaRi-Heart.

Submitted by Caristo Diagnostics , Ltd. (Stamford, US). The FDA issued a Not Cleared (DENG) decision on July 28, 2026 after a review of 327 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: Regulatory edge-case submission. High predicate equivalence gap. With 327 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

View all Caristo Diagnostics , Ltd. devices

Submission Details

510(k) Number DEN250042 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received September 04, 2025
Decision Date July 28, 2026
Days to Decision 327 days
Submission Type Direct
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
202d slower than avg
Panel avg: 125d · This submission: 327d
Pathway characteristics

Device Classification

Product Code SIU
Device Class -