Cleared Traditional

K232615 - LumiMARK Biopsy Site Marker (LM0215T (T...

Also marketed or referenced as:
LumiMARK™ Biopsy Site Marker (LM0215L (Lotus Shape)) LumiMARK™ Biopsy Site Marker (LM0215R (Rose shape))

K232615 is the FDA 510(k) clearance for LumiMARK Biopsy Site Marker (LM0215T (T... by Devicor Medical Products, Inc.. It is a Class 2 General & Plastic Surgery device (product code NEU) cleared through the Traditional 510(k) pathway after a 137-day FDA review.

K232615 · Devicor Medical Products, Inc. · General & Plastic Surgery device
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Jan 2024
Decision
137d
Days
Class 2
Risk

K232615 is an FDA 510(k) clearance for the LumiMARK™ Biopsy Site Marker (LM0215T (Tulip Shape)). Classified as Marker, Radiographic, Implantable (product code NEU), Class II - Special Controls.

Submitted by Devicor Medical Products, Inc. (Cincinnati, US). The FDA issued a Cleared decision on January 12, 2024 after a review of 137 days - within the typical 510(k) review window.

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 Devicor Medical Products, Inc. devices

Submission Details

510(k) Number K232615 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 2023
Decision Date January 12, 2024
Days to Decision 137 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
22d slower than avg
Panel avg: 115d · This submission: 137d
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 57
Devices cleared under the same product code (NEU) and FDA review panel - the closest regulatory comparables to K232615.
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