Not Cleared Direct

Syncron-E (DEN250025) - FDA 510(k) Clearance

DEN250025 · Autonomous Healthcare, Inc. · Anesthesiology device
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Jun 2026
Decision
360d
Days
-
Risk

DEN250025 is an FDA 510(k) submission (not cleared) for the Syncron-E.

Submitted by Autonomous Healthcare, Inc. (Santa Clara, US). The FDA issued a Not Cleared (DENG) decision on June 18, 2026 after a review of 360 days.

This device falls under the Anesthesiology 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 360 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 Autonomous Healthcare, Inc. devices

Submission Details

510(k) Number DEN250025 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received June 23, 2025
Decision Date June 18, 2026
Days to Decision 360 days
Submission Type Direct
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
220d slower than avg
Panel avg: 140d · This submission: 360d
Pathway characteristics

Device Classification

Product Code QVC
Device Class -