Cleared Traditional

K850354 - SYSMEX E-5000, FULLY AUTOMATED HEMATOLOGY SYS

K850354 is an FDA 510(k) clearance for SYSMEX E-5000, manufactured by Toa Medical Electronics USA, Inc.. The device is a Class 2 Hematology device with product code GKZ cleared through the Traditional 510(k) pathway after a 110-day FDA review.

K850354 · Toa Medical Electronics USA, Inc. · Hematology device
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May 1985
Decision
110d
Days
Class 2
Risk

K850354 is an FDA 510(k) clearance for the SYSMEX E-5000, FULLY AUTOMATED HEMATOLOGY SYS. Classified as Counter, Differential Cell (product code GKZ), Class II - Special Controls.

Submitted by Toa Medical Electronics USA, Inc. (Carson, US). The FDA issued a Cleared decision on May 20, 1985 after a review of 110 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 Toa Medical Electronics USA, Inc. devices

FDA 510(k) Submission Details - K850354

510(k) Number K850354 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 1985
Decision Date May 20, 1985
Days to Decision 110 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
3d faster than avg
Panel avg: 113d · This submission: 110d
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 299
Devices cleared under the same product code (GKZ) and FDA review panel - the closest regulatory comparables to K850354.
QBC CENTRIFUGAL HEMATOLOGY SYSTEM
K854242 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jan 1986
CELL-DYN 1500 MULTI-PARAMETER HEMATOLOGY ANALYZER
K854368 · Abbott Diagnostics · Jan 1986
CELL-DYN 2000 AUTOMATED MULTI-PARAMETER HEMATOLOGY
K852371 · Abbott Diagnostics · Sep 1985
SYSMEX CC-800/PDA-410 W/TRI-MODAL LEUKOCYTE SIZE -
K844910 · Toa Medical Electronics USA, Inc. · Apr 1985
QBC CENTRIFUGAL HEMATOLOGY ANALYZER
K844645 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1985
AUTOLYZER 800
K841852 · Geometric Data, Div. Smithkline Corp. · Sep 1984