Cleared Traditional

K042296 - BIOMARC PRELOADED TISSUE MARKER DEVICE

K042296 is an FDA 510(k) clearance for BIOMARC PRELOADED TISSUE MARKER DEVICE, manufactured by Carbon Medical Technologies, Inc.. The device is a Class 2 General & Plastic Surgery device with product code NEU cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K042296 · Carbon Medical Technologies, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K042296

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.

NEU Device Classification - Class 2, Special Controls

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 65
Devices cleared under the same product code (NEU) and FDA review panel - the closest regulatory comparables to K042296.
INTERV BRAND V-MARK BREAST BIOPSY SITE MARKER WITH TITANIUM ANCHOR
K053518 · Medical Device Technologies, Inc. · Jan 2006
INTER V BRAND V-MARK BREAST BIOPSY SITE MARKER WITH TITANIUM ANCHOR
K051421 · Medical Device Technologies, Inc. · Aug 2005
GEL MARK V
K050090 · Senorx, Inc. · Feb 2005
MODIFICATION TO SELF-DRILLING RADIOGRAPHIC MARKERS
K040990 · Walter Lorenz Surgical, Inc. · May 2004
GEL MARK IV
K040706 · Senorx, Inc. · Apr 2004
CLIPLOC SOFT TISSUE MARKER 18G/100MM (4), /130MM (5 1/8), /150MM (6), MODELS 12370, 12372, 12376
K033447 · Mri Devices Corp. · Jan 2004