Cleared Traditional

K133697 - BREAST-MED TISSUE MARKER (FDA 510(k) Clearance)

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

K133697 · Breast-Med, Inc. · General & Plastic Surgery device
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Apr 2015
Decision
493d
Days
Class 2
Risk

K133697 is an FDA 510(k) clearance for the BREAST-MED TISSUE MARKER. Classified as Marker, Radiographic, Implantable (product code NEU), Class II - Special Controls.

Submitted by Breast-Med, Inc. (Golden Valley, US). The FDA issued a Cleared decision on April 10, 2015 after a review of 493 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General & Plastic Surgery submissions.

View all Breast-Med, Inc. devices

Submission Details

510(k) Number K133697 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 2013
Decision Date April 10, 2015
Days to Decision 493 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
379d slower than avg
Panel avg: 114d · This submission: 493d
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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