Cleared Traditional

K012372 - SYSMEX UF-50

K012372 is the FDA 510(k) clearance for SYSMEX UF-50 by Sysmex Corp.. It is a Class 2 Pathology device (product code LKM) cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K012372 · Sysmex Corp. · Pathology device
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Sep 2001
Decision
64d
Days
Class 2
Risk

K012372 is an FDA 510(k) clearance for the SYSMEX UF-50. Classified as Counter, Urine Particle (product code LKM), Class II - Special Controls.

Submitted by Sysmex Corp. (Long Grove, US). The FDA issued a Cleared decision on September 28, 2001 after a review of 64 days - a notably fast clearance cycle.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 864.5200 - the FDA pathology 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.

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Submission Details

510(k) Number K012372 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 2001
Decision Date September 28, 2001
Days to Decision 64 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
13d faster than avg
Panel avg: 77d · This submission: 64d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LKM Counter, Urine Particle
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5200
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 Pathology devices follow this clearance model.