Cleared Traditional

K051421 - INTER V BRAND V-MARK BREAST BIOPSY SITE MARKER WITH TITANIUM ANCHOR

K051421 is an FDA 510(k) clearance for INTER V BRAND V-MARK BREAST BIOPSY SITE..., manufactured by Medical Device 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 90-day FDA review.

K051421 · Medical Device Technologies, Inc. · General & Plastic Surgery device
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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

FDA 510(k) Submission Details - K051421

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
Combination Product No
PCCP Authorized No
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.

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 105
Devices cleared under the same product code (NEU) and FDA review panel - the closest regulatory comparables to K051421.
HYDROMARK BIOPSY SITE MARKER
K060769 · Biopsy Sciences, LLC · Jul 2006
INTERV BRAND V-MARK BREAST BIOPSY SITE MARKER WITH TITANIUM ANCHOR
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KAPP BARI-RING, MODEL KS-BR-2005
K050384 · Kapp Surgical Instrument, Inc. · Jan 2006
GEL MARK V
K050090 · Senorx, Inc. · Feb 2005
BIOMARC PRELOADED TISSUE MARKER DEVICE
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ULTRACLIP II US
K042341 · Inrad · Sep 2004