Cleared Traditional

K943894 - SYSMEX K-4500

K943894 is the FDA 510(k) clearance for SYSMEX K-4500 by Sysmex Corp.. It is a Class 2 Hematology device (product code GKZ) cleared through the Traditional 510(k) pathway after a 178-day FDA review.

K943894 · Sysmex Corp. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1995
Decision
178d
Days
Class 2
Risk

K943894 is an FDA 510(k) clearance for the SYSMEX K-4500. Classified as Counter, Differential Cell (product code GKZ), Class II - Special Controls.

Submitted by Sysmex Corp. (Long Grove, US). The FDA issued a Cleared decision on February 3, 1995 after a review of 178 days - an extended review cycle.

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 Corp. devices

Submission Details

510(k) Number K943894 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 1994
Decision Date February 03, 1995
Days to Decision 178 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
65d slower than avg
Panel avg: 113d · This submission: 178d
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 K943894.
ORTHO-MUNE OKT8 (CD8) MONOCLONAL ANTIBODY (MURINE)
K932532 · Ortho Diagnostic Systems, Inc. · Apr 1995
ORTHO-MUNE 0KT 11 (CD2) MONOCLONAL ANTIBODY (MURINE)
K941713 · Ortho Diagnostic Systems, Inc. · Apr 1995
ONYX
K943967 · Coulter Corp. · Mar 1995
MONOCLONAL MOUSE ANTI-HUMAN T-CELL, CD2, CLONE MT910 FITC-CONJUGATED, (ANTI-CD2,FITC, MT910)
K945692 · Dako Corp. · Jan 1995
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