Cleared Traditional

K936023 - SYSMEX SE-9000 AUTOMATED HEMATOLOGY ANALYZER

K936023 is an FDA 510(k) clearance for SYSMEX SE-9000 AUTOMATED HEMATOLOGY ANA..., 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 138-day FDA review.

K936023 · Toa Medical Electronics USA, Inc. · Hematology device
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Optimized for regulatory review, auditing and printing
May 1994
Decision
138d
Days
Class 2
Risk

K936023 is an FDA 510(k) clearance for the SYSMEX SE-9000 AUTOMATED HEMATOLOGY ANALYZER. Classified as Counter, Differential Cell (product code GKZ), Class II - Special Controls.

Submitted by Toa Medical Electronics USA, Inc. (Los Alamitos, US). The FDA issued a Cleared decision on May 2, 1994 after a review of 138 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 - K936023

510(k) Number K936023 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 1993
Decision Date May 02, 1994
Days to Decision 138 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
25d slower than avg
Panel avg: 113d · This submission: 138d
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 298
Devices cleared under the same product code (GKZ) and FDA review panel - the closest regulatory comparables to K936023.
MONOCLONAL MOUSE ANTI-HUMAN T-CELL
K942797 · Dako Corp. · Nov 1994
AUTOCOMP(TM) SOFTWARE AND CALIBRITE(TM) BEADS
K925274 · Becton Dickinson Immunocytometry Systems · Sep 1994
FASCOUNT SYSTME
K933486 · Becton Dickinson Immunocytometry Systems · Sep 1994
FACSORT FLOW CYTOMETER
K923790 · Becton Dickinson Immunocytometry Systems · Sep 1993
COULTER MH015 (DIFFERENTIAL CELL COUNTER)
K930913 · Coulter Corp. · Aug 1993
COULTER STKS WITH RETICULOCYTE ANALYSIS CAPABILITY
K932030 · Coulter Corp. · Aug 1993