Cleared Special

K151998 - TraceIT Tissue Marker - 3mL

K151998 is an FDA 510(k) clearance for TraceIT Tissue Marker - 3mL, manufactured by Augmenix, Inc.. The device is a Class 2 General & Plastic Surgery device with product code NEU cleared through the Special 510(k) pathway after a 30-day FDA review.

K151998 · Augmenix, Inc. · General & Plastic Surgery device
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Aug 2015
Decision
30d
Days
Class 2
Risk

K151998 is an FDA 510(k) clearance for the TraceIT Tissue Marker - 3mL. Classified as Marker, Radiographic, Implantable (product code NEU), Class II - Special Controls.

Submitted by Augmenix, Inc. (Waltham, US). The FDA issued a Cleared decision on August 19, 2015 after a review of 30 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4300 - 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 Augmenix, Inc. devices

FDA 510(k) Submission Details - K151998

510(k) Number K151998 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 2015
Decision Date August 19, 2015
Days to Decision 30 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
85d faster than avg
Panel avg: 115d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

NEU Device Classification - Class 2, Special Controls

Product Code NEU Marker, Radiographic, Implantable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4300
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 - NEU Marker, Radiographic, Implantable

All 92
Devices cleared under the same product code (NEU) and FDA review panel - the closest regulatory comparables to K151998.
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BREAST-MED TISSUE MARKER
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