Cleared Traditional

K050384 - KAPP BARI-RING

K050384 is an FDA 510(k) clearance for KAPP BARI-RING, manufactured by Kapp Surgical Instrument, Inc.. The device is a Class 2 General & Plastic Surgery device with product code NEU cleared through the Traditional 510(k) pathway after a 332-day FDA review.

K050384 · Kapp Surgical Instrument, Inc. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Jan 2006
Decision
332d
Days
Class 2
Risk

K050384 is an FDA 510(k) clearance for the KAPP BARI-RING, MODEL KS-BR-2005. Classified as Marker, Radiographic, Implantable (product code NEU), Class II - Special Controls.

Submitted by Kapp Surgical Instrument, Inc. (Warrensville, US). The FDA issued a Cleared decision on January 13, 2006 after a review of 332 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Kapp Surgical Instrument, Inc. devices

FDA 510(k) Submission Details - K050384

510(k) Number K050384 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 15, 2005
Decision Date January 13, 2006
Days to Decision 332 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
217d slower than avg
Panel avg: 115d · This submission: 332d
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 K050384.
PROSTATE TISSUE MARKER
K081170 · Senorx, Inc. · May 2008
GEL MARK ULTRACOR BIOPSY SITE MARKER, MODEL: GMUC-17GGP
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
MODIFICATION TO SELF-DRILLING RADIOGRAPHIC MARKERS
K040990 · Walter Lorenz Surgical, Inc. · May 2004