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
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

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
40d slower than avg
Panel avg: 78d · 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 14
Devices cleared under the same product code (LKM) and FDA review panel - the closest regulatory comparables to K083002.
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K093861 · Iris International, Inc. · Feb 2010
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K070910 · Sysmex America, Inc. · May 2007
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K053135 · Sysmex America, Inc. · Jan 2006
K083002 · SYSMEX UF-500I AUTOMATED URINE PARTICLE ANALYZER
Download PDF FDA Summary Sysmex America, Inc.