Cleared Traditional

K855116 - SYSMEX E-5000 FULLY AUTOMATED HEMATOLOG...

K855116 is the FDA 510(k) clearance for SYSMEX E-5000 FULLY AUTOMATED HEMATOLOG... 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 63-day FDA review.

K855116 · Toa Medical Electronics USA, Inc. · Hematology device
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Feb 1986
Decision
63d
Days
Class 2
Risk

K855116 is an FDA 510(k) clearance for the SYSMEX E-5000 FULLY AUTOMATED HEMATOLOGY SYSTEM. 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 February 24, 1986 after a review of 63 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Toa Medical Electronics USA, Inc. devices

Submission Details

510(k) Number K855116 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 1985
Decision Date February 24, 1986
Days to Decision 63 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
50d faster than avg
Panel avg: 113d · This submission: 63d
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 K855116.
SYSMEX F-800 15 PARAMETER, SEMI-AUTO HEMA ANALYZER
K873734 · Toa Medical Electronics USA, Inc. · Nov 1987
COULTER COUNTER MODEL S-PLUS STKR
K871837 · Coulter Electronics, Inc. · Jul 1987
SYSMEX M-2000 18-PARAMETER, FULLY AUTO HEMA ANALY.
K871600 · Toa Medical Electronics USA, Inc. · Jun 1987
SYSMEX E-2500 AUTOMATED HEMATOLOGY SYSTEM
K855117 · Toa Medical Electronics USA, Inc. · Feb 1986
TECHNICON H*1 SYSTEM (MPXI)
K853027 · Technicon Instruments Corp. · Feb 1986
TECHNICON H*1 SYSTEM LOBULARITY INDX/LFT SHIFT FLA
K853029 · Technicon Instruments Corp. · Jan 1986