Cleared Traditional

K142198 - BNX Fine Needle Aspiration System

K142198 is the FDA 510(k) clearance for BNX Fine Needle Aspiration System by Covidien, LLC. It is a Class 2 General & Plastic Surgery device (product code NEU) cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K142198 · Covidien, LLC · General & Plastic Surgery device
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Oct 2014
Decision
58d
Days
Class 2
Risk

K142198 is an FDA 510(k) clearance for the BNX Fine Needle Aspiration System. Classified as Marker, Radiographic, Implantable (product code NEU), Class II - Special Controls.

Submitted by Covidien, LLC (Auburndale, US). The FDA issued a Cleared decision on October 8, 2014 after a review of 58 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Covidien, LLC devices

Submission Details

510(k) Number K142198 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 2014
Decision Date October 08, 2014
Days to Decision 58 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
57d faster than avg
Panel avg: 115d · This submission: 58d
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 50
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