Cleared Traditional

K021241 - SYSMEX XT-SERIES, MODEL XT-2000I AND XT-1800I

K021241 is an FDA 510(k) clearance for SYSMEX XT-SERIES, manufactured by Sysmex Corporation of America. The device is a Class 2 Hematology device with product code GKZ cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K021241 · Sysmex Corporation of America · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2002
Decision
67d
Days
Class 2
Risk

K021241 is an FDA 510(k) clearance for the SYSMEX XT-SERIES, MODEL XT-2000I AND XT-1800I. Classified as Counter, Differential Cell (product code GKZ), Class II - Special Controls.

Submitted by Sysmex Corporation of America (Long Grove, US). The FDA issued a Cleared decision on June 25, 2002 after a review of 67 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5220 - 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 - K021241

510(k) Number K021241 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 2002
Decision Date June 25, 2002
Days to Decision 67 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
46d faster than avg
Panel avg: 113d · This submission: 67d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GKZ Device Classification - Class 2, Special Controls

Product Code GKZ Counter, Differential Cell
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5220
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 - GKZ Counter, Differential Cell

All 296
Devices cleared under the same product code (GKZ) and FDA review panel - the closest regulatory comparables to K021241.
CYTO-STAT TETRACHROME CD45-FIT/CD4-PE/CD3-PC5 MONOCLONAL ANTIBODY REAGENT, CYTO-STAT TETRACHROM CD45-FITC/CD56-PE/CD19-A
K030408 · Beckman Coulter, Inc. · Mar 2003
ADVIA 120 HEMATOLOGY SYSTEM COMPLETE BLOOD COUNT (CBC) METHOD
K022668 · Bayer Diagnostics Corp. · Oct 2002
MODIFICATION TO COULTER LH 750 HEMATOLOGY ANALYZER, MODEL 6605632
K022161 · Beckman Coulter, Inc. · Jul 2002
CELL-DYN 3200 SYSTEM WITH ABSOLUTE AND PERCENT RETICULOCYTE
K012934 · Abbott Laboratories · Sep 2001
ADVIA 120 HEMATOLOGY SYSTEM, CYANIDE-FREE HIGH DETERMINATION
K012904 · Bayer Diagnostics Corp. · Sep 2001
COULTER LH 750 HEMATOLOGY ANALYZER, MODEL 6605632
K011342 · Beckman Coulter, Inc. · Jul 2001