Not Cleared Direct

DEN200041 - Comfort Marker 2.0. (FDA 510(k) Clearance)

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

DEN200041 · Medical Precision BV · Radiology device
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Dec 2021
Decision
536d
Days
Class 2
Risk

DEN200041 is an FDA 510(k) submission (not cleared) for the Comfort Marker 2.0.. Classified as Radiation Therapy Marking Device (product code QRN), Class II - Special Controls.

Submitted by Medical Precision BV (Zwolle, NL). The FDA issued a Not Cleared (DENG) decision on December 10, 2021 after a review of 536 days.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5785 - the FDA radiology and imaging software oversight 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 536 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 DEN200041 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received June 22, 2020
Decision Date December 10, 2021
Days to Decision 536 days
Submission Type Direct
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
429d slower than avg
Panel avg: 107d · This submission: 536d
Pathway characteristics

Device Classification

Product Code QRN Radiation Therapy Marking Device
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5785
Definition A Radiation Therapy Marking Device Is A Powered Device That Transdermally Delivers A Permanent Or Temporary Colorant To The Skin For The Purpose Of Placing Marks To Guide Radiation Therapy. This Classification Does Not Include Devices With Reusable Or Reprocessed Needles Or Devices Intended For Diagnostic, Therapeutic, Or Aesthetic Use Or To Deliver Other Products For These Uses.
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 Radiology devices follow this clearance model.