Cleared Traditional

K071967 - SYSMEX XE-5000

K071967 is an FDA 510(k) clearance for SYSMEX XE-5000, 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 127-day FDA review.

K071967 · Sysmex America, Inc. · Hematology device
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Nov 2007
Decision
127d
Days
Class 2
Risk

K071967 is an FDA 510(k) clearance for the SYSMEX XE-5000. 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 November 20, 2007 after a review of 127 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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

FDA 510(k) Submission Details - K071967

510(k) Number K071967 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 2007
Decision Date November 20, 2007
Days to Decision 127 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
14d slower than avg
Panel avg: 113d · This submission: 127d
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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