Cleared Traditional

BIOMARC PRELOADED TISSUE MARKER DEVICE (K042296) - FDA 510(k) Clearance

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

K042296 · Carbon Medical Technologies, Inc. · General & Plastic Surgery device
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Sep 2004
Decision
27d
Days
Class 2
Risk

K042296 is an FDA 510(k) clearance for the BIOMARC PRELOADED TISSUE MARKER DEVICE. Classified as Marker, Radiographic, Implantable (product code NEU), Class II - Special Controls.

Submitted by Carbon Medical Technologies, Inc. (St. Paul, US). The FDA issued a Cleared decision on September 20, 2004 after a review of 27 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Carbon Medical Technologies, Inc. devices

Submission Details

510(k) Number K042296 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 2004
Decision Date September 20, 2004
Days to Decision 27 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
88d faster than avg
Panel avg: 115d · This submission: 27d
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 48
Devices cleared under the same product code (NEU) and FDA review panel - the closest regulatory comparables to K042296.
SENOMARK ULTRA BREAST TISSUE MARKER
K123911 · C.R. Bard, Inc. · Jan 2013
SECRMARK BIOPSY SITE MARKING SYSTEM
K102768 · Hologic, Inc. · Dec 2010
ULTRACLIP II US WING AND COIL, MODELS: 862017U, 864017U
K090547 · C.R. Bard, Inc. · Mar 2009
8 GAUGE MICROMARK II TISSUE MARKER, MODELS C1540 & C1535
K020276 · Ethicon Endo-Surgery, Inc. · Apr 2002
MICROMARK II TISSUE MARKER,MODEL C1535
K013413 · Ethicon Endo-Surgery, Inc. · Dec 2001
TANTALUM BEADS - RADIOGRAPHIC MARKER
K010348 · Biomet, Inc. · May 2001