Cleared Traditional

K012372 - SYSMEX UF-50

K012372 is an FDA 510(k) clearance for SYSMEX UF-50, 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 64-day FDA review.

K012372 · Sysmex Corp. · Pathology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K012372

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
14d faster than avg
Panel avg: 78d · This submission: 64d
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.

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 K012372.
SYSMEX MODEL UF1000I
K070910 · Sysmex America, Inc. · May 2007
SYSMEX UF-100I AUTOMATED URINE CELL ANALYZER
K053135 · Sysmex America, Inc. · Jan 2006
IQ 200 SYSTEM
K022774 · Intl. Remote Imaging Systems · Oct 2002
939UDX URINE PATHOLOGY SYSTEM
K000373 · Intl. Remote Imaging Systems · Apr 2000
SYSMEX UF-100
K961054 · Sysmex Corp. · Oct 1996
HEMATOLOGY COMPUTER-INTERFACE, VISCOUNT
K822823 · Eko Scann AB · Oct 1982
K012372 · SYSMEX UF-50
Download PDF FDA Summary Sysmex Corp.