Cleared Traditional

K093473 - KMD-MARK1 TISSUE MARKER (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K093473 · Kent Medical Devices, Inc. · General & Plastic Surgery device
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Jul 2010
Decision
238d
Days
Class 2
Risk

K093473 is an FDA 510(k) clearance for the KMD-MARK1 TISSUE MARKER. Classified as Marker, Radiographic, Implantable (product code NEU), Class II - Special Controls.

Submitted by Kent Medical Devices, Inc. (Washington, US). The FDA issued a Cleared decision on July 2, 2010 after a review of 238 days - an extended review 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. 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 General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Kent Medical Devices, Inc. devices

Submission Details

510(k) Number K093473 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 2009
Decision Date July 02, 2010
Days to Decision 238 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
124d slower than avg
Panel avg: 114d · This submission: 238d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 109
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