Not Cleared Direct

DEN230011 - OcuCool (FDA 510(k) Clearance)

DEN230011 · Recensmedical, Inc. · Ophthalmic device
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Sep 2024
Decision
592d
Days
-
Risk

DEN230011 is an FDA 510(k) submission (not cleared) for the OcuCool.

Submitted by Recensmedical, Inc. (Hwaseong-Si, KR). The FDA issued a Not Cleared (DENG) decision on September 30, 2024 after a review of 592 days.

This device falls under the Ophthalmic 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 592 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 Recensmedical, Inc. devices

Submission Details

510(k) Number DEN230011 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received February 16, 2023
Decision Date September 30, 2024
Days to Decision 592 days
Submission Type Direct
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
482d slower than avg
Panel avg: 110d · This submission: 592d
Pathway characteristics

Device Classification

Product Code QZQ
Device Class -