Cleared Traditional

K040073 - SYSMEX AUTOMATED HEMATOLOGY ANALYZER, XE-2100 SERIES (XE-2100, XE-2100L)

K040073 is an FDA 510(k) clearance for SYSMEX AUTOMATED HEMATOLOGY ANALYZER, manufactured by Sysmex America, Inc.. The device is a Class 2 Hematology device with product code GKZ cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K040073 · Sysmex America, Inc. · Hematology device
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Optimized for regulatory review, auditing and printing
Mar 2004
Decision
64d
Days
Class 2
Risk

K040073 is an FDA 510(k) clearance for the SYSMEX AUTOMATED HEMATOLOGY ANALYZER, XE-2100 SERIES (XE-2100, XE-2100L). Classified as Counter, Differential Cell (product code GKZ), Class II - Special Controls.

Submitted by Sysmex America, Inc. (Mundelein, US). The FDA issued a Cleared decision on March 18, 2004 after a review of 64 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 America, Inc. devices

FDA 510(k) Submission Details - K040073

510(k) Number K040073 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 14, 2004
Decision Date March 18, 2004
Days to Decision 64 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 113d · This submission: 64d
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 295
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