Cleared Special

K083002 - SYSMEX UF-500I AUTOMATED URINE PARTICLE ANALYZER

K083002 is an FDA 510(k) clearance for SYSMEX UF-500I AUTOMATED URINE PARTICLE..., manufactured by Sysmex America, Inc.. The device is a Class 2 Pathology device with product code LKM cleared through the Special 510(k) pathway after a 118-day FDA review.

K083002 · Sysmex America, Inc. · Pathology device
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Feb 2009
Decision
118d
Days
Class 2
Risk

K083002 is an FDA 510(k) clearance for the SYSMEX UF-500I AUTOMATED URINE PARTICLE ANALYZER. Classified as Counter, Urine Particle (product code LKM), Class II - Special Controls.

Submitted by Sysmex America, Inc. (Mundelein, US). The FDA issued a Cleared decision on February 3, 2009 after a review of 118 days - within the typical 510(k) review window.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 864.5200 - the FDA pathology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Sysmex America, Inc. devices

FDA 510(k) Submission Details - K083002

510(k) Number K083002 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 08, 2008
Decision Date February 03, 2009
Days to Decision 118 days
Submission Type Special
Review Panel Pathology (PA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
41d slower than avg
Panel avg: 77d · This submission: 118d
Pathway characteristics
Modification to existing cleared device.

LKM Device Classification - Class 2, Special Controls

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.

Regulatory Peers - LKM Counter, Urine Particle

All 10
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