Cleared Traditional

EasyMark Tissue Marker (K183503) - FDA 510(k) Clearance

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

K183503 · Inrad, Inc. · General & Plastic Surgery device
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Oct 2019
Decision
304d
Days
Class 2
Risk

K183503 is an FDA 510(k) clearance for the EasyMark Tissue Marker. Classified as Marker, Radiographic, Implantable (product code NEU), Class II - Special Controls.

Submitted by Inrad, Inc. (Kentwood, US). The FDA issued a Cleared decision on October 17, 2019 after a review of 304 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Inrad, Inc. devices

Submission Details

510(k) Number K183503 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 2018
Decision Date October 17, 2019
Days to Decision 304 days
Submission Type Traditional
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
189d slower than avg
Panel avg: 115d · This submission: 304d
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 47
Devices cleared under the same product code (NEU) and FDA review panel - the closest regulatory comparables to K183503.
HydroMARK Breast Biopsy Site Markers
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BioZorb SP Marker
K192371 · Focal Therapeutics · Sep 2019
RFID Localization System
K190932 · Health Beacons, Inc. · Sep 2019
SignalMark Breast Marker
K190689 · View Point Medical, Inc. · Aug 2019