Cleared Traditional

K000373 - 939UDX URINE PATHOLOGY SYSTEM

K000373 is an FDA 510(k) clearance for 939UDX URINE PATHOLOGY SYSTEM, manufactured by Intl. Remote Imaging Systems. The device is a Class 2 Pathology device with product code LKM cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K000373 · Intl. Remote Imaging Systems · Pathology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2000
Decision
70d
Days
Class 2
Risk

K000373 is an FDA 510(k) clearance for the 939UDX URINE PATHOLOGY SYSTEM. Classified as Counter, Urine Particle (product code LKM), Class II - Special Controls.

Submitted by Intl. Remote Imaging Systems (Chatsworth, US). The FDA issued a Cleared decision on April 14, 2000 after a review of 70 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 - K000373

510(k) Number K000373 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 2000
Decision Date April 14, 2000
Days to Decision 70 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
8d faster than avg
Panel avg: 78d · This submission: 70d
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 K000373.
SYSMEX UF-100I AUTOMATED URINE CELL ANALYZER
K053135 · Sysmex America, Inc. · Jan 2006
IQ 200 SYSTEM
K022774 · Intl. Remote Imaging Systems · Oct 2002
SYSMEX UF-50
K012372 · Sysmex Corp. · Sep 2001
SYSMEX UF-100
K961054 · Sysmex Corp. · Oct 1996
HEMATOLOGY COMPUTER-INTERFACE, VISCOUNT
K822823 · Eko Scann AB · Oct 1982
K000373 · 939UDX URINE PATHOLOGY SYSTEM
Download PDF FDA Summary Intl. Remote Imaging …