Not Cleared Direct

DEN230067 - Chronos® (FDA 510(k) Clearance)

Class II General Hospital device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN230067 · Germitec · General Hospital
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Aug 2024
Decision
335d
Days
Class 2
Risk

DEN230067 is an FDA 510(k) submission (not cleared) for the Chronos®. Classified as Ultraviolet Radiation Disinfection Chamber Device (product code SCS), Class II - Special Controls.

Submitted by Germitec (Bordeaux, FR). The FDA issued a Not Cleared (DENG) decision on August 28, 2024 after a review of 335 days.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6511 - the FDA general hospital device framework. 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 335 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.

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Submission Details

510(k) Number DEN230067 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received September 28, 2023
Decision Date August 28, 2024
Days to Decision 335 days
Submission Type Direct
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
207d slower than avg
Panel avg: 128d · This submission: 335d
Pathway characteristics

Device Classification

Product Code SCS Ultraviolet Radiation Disinfection Chamber Device
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6511
Definition An Ultraviolet Radiation Disinfection Chamber Device Is Intended To Disinfect Patient Contacting Medical Devices Using Uv Radiation After The Device Has Been Cleaned. Disinfection Of The Medical Device Is Achieved Within An Enclosed Chamber Through The Exposure To Uv Radiation.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.