Cleared Traditional

INTER V BRAND V-MARK BREAST BIOPSY SITE MARKER WITH TITANIUM ANCHOR (K051421) - FDA 510(k) Clearance

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

K051421 · Medical Device Technologies, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2005
Decision
90d
Days
Class 2
Risk

K051421 is an FDA 510(k) clearance for the INTER V BRAND V-MARK BREAST BIOPSY SITE MARKER WITH TITANIUM ANCHOR. Classified as Marker, Radiographic, Implantable (product code NEU), Class II - Special Controls.

Submitted by Medical Device Technologies, Inc. (Gainesville, US). The FDA issued a Cleared decision on August 30, 2005 after a review of 90 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 Medical Device Technologies, Inc. devices

Submission Details

510(k) Number K051421 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 2005
Decision Date August 30, 2005
Days to Decision 90 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
25d faster than avg
Panel avg: 115d · This submission: 90d
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 44
Devices cleared under the same product code (NEU) and FDA review panel - the closest regulatory comparables to K051421.
Magseed Magnetic Marker Systtem
K173587 · Endomagnetics Ltd., · Feb 2018
SENOMARK ULTRA BREAST TISSUE MARKER
K123911 · C.R. Bard, Inc. · Jan 2013
ULTRACLIP II US WING AND COIL, MODELS: 862017U, 864017U
K090547 · C.R. Bard, Inc. · Mar 2009
TANTALUM BEADS - RADIOGRAPHIC MARKER
K010348 · Biomet, Inc. · May 2001