Cleared Traditional

K936023 - SYSMEX SE-9000 AUTOMATED HEMATOLOGY ANA...

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

K936023 · Toa Medical Electronics USA, Inc. · Hematology device
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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

Submission Details

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
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.

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 194
Devices cleared under the same product code (GKZ) and FDA review panel - the closest regulatory comparables to K936023.
MONOCLONAL MOUSE ANTI-HUMAN B-CELL
K943284 · Dako Corp. · Nov 1994
MONOCLONAL MOUSE ANTI-HUMAN T-CELL, CD8, RPE-CONJUGATED, CLONE DK25
K944253 · Dako Corp. · Nov 1994
MONOCLONAL MOUSE ANTI-HUMAN T-CELL
K942797 · Dako Corp. · Nov 1994
COULTER MH015 (DIFFERENTIAL CELL COUNTER)
K930913 · Coulter Corp. · Aug 1993
COULTER STKS WITH RETICULOCYTE ANALYSIS CAPABILITY
K932030 · Coulter Corp. · Aug 1993
ABBOTT ENCOUNTER(TM)Q
K930309 · Abbott Laboratories · Jul 1993