Cleared Traditional

K850354 - SYSMEX E-5000

K850354 is the FDA 510(k) clearance for SYSMEX E-5000 by Toa Medical Electronics USA, Inc.. It is a Class 2 Hematology device (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

Submission Details

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.

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 206
Devices cleared under the same product code (GKZ) and FDA review panel - the closest regulatory comparables to K850354.
TECHNICON H*1 SYSTEM LOBULARITY INDX/LFT SHIFT FLA
K853029 · Technicon Instruments Corp. · Jan 1986
TECHNICON H*1 SYSTEM SUB-CLASSIFICATION LUC CAT.
K852988 · Technicon Instruments Corp. · Jan 1986
QBC CENTRIFUGAL HEMATOLOGY SYSTEM
K854242 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jan 1986
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
TECHNICON H*1 SYSTEM
K842636 · Technicon Instruments Corp. · Jul 1984