Cleared Traditional

K001683 - SYSMEX R-500

K001683 is an FDA 510(k) clearance for SYSMEX R-500, manufactured by Sysmex Corporation of America. The device is a Class 2 Hematology device with product code GKL cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K001683 · Sysmex Corporation of America · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2000
Decision
81d
Days
Class 2
Risk

K001683 is an FDA 510(k) clearance for the SYSMEX R-500. Classified as Counter, Cell, Automated (particle Counter) (product code GKL), Class II - Special Controls.

Submitted by Sysmex Corporation of America (Long Grove, US). The FDA issued a Cleared decision on August 21, 2000 after a review of 81 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Sysmex Corporation of America devices

FDA 510(k) Submission Details - K001683

510(k) Number K001683 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 2000
Decision Date August 21, 2000
Days to Decision 81 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 113d · This submission: 81d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GKL Device Classification - Class 2, Special Controls

Product Code GKL Counter, Cell, Automated (particle Counter)
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 - GKL Counter, Cell, Automated (particle Counter)

All 98
Devices cleared under the same product code (GKL) and FDA review panel - the closest regulatory comparables to K001683.
IQ 200 URINE ANALYZER BODY FLUIDS MODULE
K050235 · Iris International, Inc. · Mar 2005
SYSMEX POCH-100I
K032677 · Sysmex America, Inc. · Feb 2004
ADVIA 120 HEMATOLOGY SYSTEM, CEREBROSPINAL FLUID METHOD
K022331 · Bayer Diagnostics Corp. · Sep 2002
COULTER Z2 ANALYZER
K991070 · Coulter Corp. · May 1999
SYSMEX R-3500, AUTOMATED RETICCULOCYTE ANALYZER, MODEL R-3500
K981950 · Sysmex Corp. · Nov 1998
SYSMEX KX-21, AUTOMATED HEMATOLOGY ANALYZER
K981761 · Sysmex Corp. · Aug 1998