Cleared Traditional

K222112 - Comfort Marker 2.0 (FDA 510(k) Clearance)

Class II Radiology device cleared through predicate-based substantial equivalence.

K222112 · Medical Precision BV · Radiology device
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Optimized for regulatory review, auditing and printing
Mar 2023
Decision
255d
Days
Class 2
Risk

K222112 is an FDA 510(k) clearance 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 Cleared decision on March 30, 2023 after a review of 255 days - an extended review cycle.

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 establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Medical Precision BV devices

Submission Details

510(k) Number K222112 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 2022
Decision Date March 30, 2023
Days to Decision 255 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
148d slower than avg
Panel avg: 107d · This submission: 255d
Pathway characteristics
Predicate-based equivalence.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Radiology devices follow this clearance model.

Regulatory Consultant

Msquared Associates, Inc.
Cherita Jones

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Clinical Evidence

ClinicalTrials.gov
NCT05371795 Unknown Interventional

Comparison on Radiotherapy Permanent Skin Marking With Lancets and an Electric Marking Device

Research Study: Tattooing of Skin Landmarks in Radiotherapy: Comparison Between the System Traditional and Comfort Marker 2.0® (COMFORTATTOO)

100
Patients (actual)
1
Site
Other
Purpose
Double blind
Masking
Condition studied Radiotherapy; Tattooing
Study design Parallel
Eligibility All sexes · 18 Years+
Sponsor Instituto Portugues de Oncologia, Francisco Gentil, Porto
Started 2021-10-18 → Primary completion 2022-03-11 → Completed 2022-09-01
Primary outcome
Patients' comfort
Secondary outcome
RTTs' satisfaction
View full study on ClinicalTrials.gov