Cleared Traditional

SYSMEX MODEL XT-4000I (K091313) - FDA 510(k) Clearance

Class II Hematology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K091313 · Sysmex America, Inc. · Hematology device
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Mar 2010
Decision
330d
Days
Class 2
Risk

K091313 is an FDA 510(k) clearance for the SYSMEX MODEL XT-4000I. 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 30, 2010 after a review of 330 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Sysmex America, Inc. devices

Submission Details

510(k) Number K091313 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 2009
Decision Date March 30, 2010
Days to Decision 330 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
217d slower than avg
Panel avg: 113d · This submission: 330d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 379
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