Cleared Special

K191797 - BiomarC Fiducial Marker

K191797 is the FDA 510(k) clearance for BiomarC Fiducial Marker by Carbon Medical Technologies. It is a Class 2 General & Plastic Surgery device (product code IYE) cleared through the Special 510(k) pathway after a 26-day FDA review.

K191797 · Carbon Medical Technologies · General & Plastic Surgery device
Download Printable Device Report (PDF)
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Jul 2019
Decision
26d
Days
Class 2
Risk

K191797 is an FDA 510(k) clearance for the BiomarC Fiducial Marker. Classified as Accelerator, Linear, Medical (product code IYE), Class II - Special Controls.

Submitted by Carbon Medical Technologies (St. Paul, US). The FDA issued a Cleared decision on July 29, 2019 after a review of 26 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 892.5050 - the FDA general and plastic surgery device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Carbon Medical Technologies devices

Submission Details

510(k) Number K191797 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 2019
Decision Date July 29, 2019
Days to Decision 26 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
89d faster than avg
Panel avg: 115d · This submission: 26d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code IYE Accelerator, Linear, Medical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5050
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 & Plastic Surgery devices follow this clearance model.

Regulatory Peers - IYE Accelerator, Linear, Medical

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