Not Cleared Direct

DEN250034 - Claria System

DEN250034 · Claria Medical, Inc. · Obstetrics & Gynecology device
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Jul 2026
Decision
329d
Days
-
Risk

DEN250034 is an FDA 510(k) submission (not cleared) for the Claria System.

Submitted by Claria Medical, Inc. (Mountain View, US). The FDA issued a Not Cleared (DENG) decision on July 2, 2026 after a review of 329 days.

This device falls under the Obstetrics & Gynecology 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 329 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 Claria Medical, Inc. devices

Submission Details

510(k) Number DEN250034 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received August 07, 2025
Decision Date July 02, 2026
Days to Decision 329 days
Submission Type Direct
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
169d slower than avg
Panel avg: 160d · This submission: 329d
Pathway characteristics

Device Classification

Product Code SIM
Device Class -