Cleared Traditional

K002165 - LINEZOLID

K002165 is an FDA 510(k) clearance for LINEZOLID, manufactured by Dickinson, and Co.. The device is a Class 2 Microbiology device with product code JTN cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K002165 · Dickinson, and Co. · Microbiology device
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Sep 2000
Decision
49d
Days
Class 2
Risk

K002165 is an FDA 510(k) clearance for the LINEZOLID, 30UG, BBL SENSI-DISC. Classified as Susceptibility Test Discs, Antimicrobial (product code JTN), Class II - Special Controls.

Submitted by Dickinson, and Co. (Sparks, US). The FDA issued a Cleared decision on September 5, 2000 after a review of 49 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.1620 - the FDA microbiology 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 Dickinson, and Co. devices

FDA 510(k) Submission Details - K002165

510(k) Number K002165 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 2000
Decision Date September 05, 2000
Days to Decision 49 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 102d · This submission: 49d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JTN Device Classification - Class 2, Special Controls

Product Code JTN Susceptibility Test Discs, Antimicrobial
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.1620
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 Microbiology devices follow this clearance model.

Regulatory Peers - JTN Susceptibility Test Discs, Antimicrobial

All 314
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