Cleared Traditional

K050384 - KAPP BARI-RING, MODEL KS-BR-2005 (FDA 510(k) Clearance)

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

K050384 · Kapp Surgical Instrument, Inc. · General & Plastic Surgery device
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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

Submission Details

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
218d slower than avg
Panel avg: 114d · This submission: 332d
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 109
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