Not Cleared Direct

DEN260007 - SmartRead(TM) Medical Device Identifier (4100)

DEN260007 · BridgeSource Medical Corporation · Cardiovascular device
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Sep 2026
Decision
189d
Days
-
Risk

DEN260007 is an FDA 510(k) submission (not cleared) for the SmartRead(TM) Medical Device Identifier (4100).

Submitted by BridgeSource Medical Corporation (Austin, US). The FDA issued a Not Cleared (DENG) decision on September 29, 2026 after a review of 189 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.

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FDA 510(k) Submission Details - DEN260007

510(k) Number DEN260007 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received March 24, 2026
Decision Date September 29, 2026
Days to Decision 189 days
Submission Type Direct
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
64d slower than avg
Panel avg: 125d · This submission: 189d
Pathway characteristics

SJJ Device Classification - Class ,

Product Code SJJ
Device Class -