Cleared Traditional

K961054 - SYSMEX UF-100

K961054 is an FDA 510(k) clearance for SYSMEX UF-100, manufactured by Sysmex Corp.. The device is a Class 2 Pathology device with product code LKM cleared through the Traditional 510(k) pathway after a 224-day FDA review.

K961054 · Sysmex Corp. · Pathology device
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Optimized for regulatory review, auditing and printing
Oct 1996
Decision
224d
Days
Class 2
Risk

K961054 is an FDA 510(k) clearance for the SYSMEX UF-100. 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 October 28, 1996 after a review of 224 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Pathology review framework, consistent with the majority of Class II 510(k) submissions.

View all Sysmex Corp. devices

FDA 510(k) Submission Details - K961054

510(k) Number K961054 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 1996
Decision Date October 28, 1996
Days to Decision 224 days
Submission Type Traditional
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
146d slower than avg
Panel avg: 78d · This submission: 224d
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 Pathology devices follow this clearance model.