Cleared Traditional

K072219 - CYTOPHIL TISSUE MARKER

K072219 is an FDA 510(k) clearance for CYTOPHIL TISSUE MARKER, manufactured by Cytophil, Inc.. The device is a Class 2 General & Plastic Surgery device with product code NEU cleared through the Traditional 510(k) pathway after a 161-day FDA review.

K072219 · Cytophil, Inc. · General & Plastic Surgery device
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Jan 2008
Decision
161d
Days
Class 2
Risk

K072219 is an FDA 510(k) clearance for the CYTOPHIL TISSUE MARKER. Classified as Marker, Radiographic, Implantable (product code NEU), Class II - Special Controls.

Submitted by Cytophil, Inc. (Whitefish Bay, US). The FDA issued a Cleared decision on January 18, 2008 after a review of 161 days - an extended review 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: 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 Cytophil, Inc. devices

FDA 510(k) Submission Details - K072219

510(k) Number K072219 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 2007
Decision Date January 18, 2008
Days to Decision 161 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
46d slower than avg
Panel avg: 115d · This submission: 161d
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 K072219.
STARCHMARK BIOPSY SITE MARKER, MODEL STMKEC-10GSS, STMKEC-10GTR, STMKMT-11GS
K081085 · Senorx, Inc. · Aug 2008
PROSTATE TISSUE MARKER
K081170 · Senorx, Inc. · May 2008
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K080698 · Senorx, Inc. · Mar 2008
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