Cleared Traditional

K883997 - SYSMEX NE-8000

K883997 is an FDA 510(k) clearance for SYSMEX NE-8000, 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 76-day FDA review.

K883997 · Toa Medical Electronics USA, Inc. · Hematology device
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Dec 1988
Decision
76d
Days
Class 2
Risk

K883997 is an FDA 510(k) clearance for the SYSMEX NE-8000. 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 December 5, 1988 after a review of 76 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

FDA 510(k) Submission Details - K883997

510(k) Number K883997 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 1988
Decision Date December 05, 1988
Days to Decision 76 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
37d faster than avg
Panel avg: 113d · This submission: 76d
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 K883997.
CELL-DYN 3000 MULTI-PARAMETER HEMATOLOGY ANALYER
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COULTER 5P CONTROL
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K885093 · Coulter Electronics, Inc. · Dec 1988
SYSMEX K-1000 18 PARAMETER, AUTO. HEMA ANALYZER
K882370 · Toa Medical Electronics USA, Inc. · Aug 1988
COULTER VCS LEUKOCYTE DIFFERENTIAL COUNTER
K880507 · Coulter Electronics, Inc. · Apr 1988
COULTER CLONE T11 MONOCLONAL ANTIBODY
K875047 · Coulter Electronics, Inc. · Mar 1988