Cleared Traditional

K171883 - Sysmex UF-5000 Fully Automated Urine Particle Analyzer

K171883 is an FDA 510(k) clearance for Sysmex UF-5000 Fully Automated Urine Pa..., manufactured by Sysmex America, Inc.. The device is a Class 2 Hematology device with product code LKM cleared through the Traditional 510(k) pathway after a 304-day FDA review.

K171883 · Sysmex America, Inc. · Hematology device
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Apr 2018
Decision
304d
Days
Class 2
Risk

K171883 is an FDA 510(k) clearance for the Sysmex UF-5000 Fully Automated Urine Particle Analyzer. Classified as Counter, Urine Particle (product code LKM), Class II - Special Controls.

Submitted by Sysmex America, Inc. (Lincolnshire, US). The FDA issued a Cleared decision on April 23, 2018 after a review of 304 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5200 - the FDA hematology 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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Sysmex America, Inc. devices

FDA 510(k) Submission Details - K171883

510(k) Number K171883 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 2017
Decision Date April 23, 2018
Days to Decision 304 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
191d slower than avg
Panel avg: 113d · This submission: 304d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Hematology devices follow this clearance model.

Regulatory Peers - LKM Counter, Urine Particle

All 10
Devices cleared under the same product code (LKM) and FDA review panel - the closest regulatory comparables to K171883.
AUTION EYE AI-4510 Urine Particle Analysis System
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K200811 · Roche Diagnostics · Nov 2020
SYSMEX UF-500I AUTOMATED URINE PARTICLE ANALYZER
K083002 · Sysmex America, Inc. · Feb 2009
SYSMEX UF-1000I, AUTOMATED URINE PARTICLE ANALYZER WITH URINALYSIS WAM SOFTWARE
K080887 · Sysmex America, Inc. · May 2008
SYSMEX MODEL UF1000I
K070910 · Sysmex America, Inc. · May 2007