Cleared Traditional

K885028 - COULTER 5P CONTROL

K885028 is an FDA 510(k) clearance for COULTER 5P CONTROL, manufactured by Coulter Electronics, Inc.. The device is a Class 2 Hematology device with product code GKZ cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K885028 · Coulter Electronics, Inc. · Hematology device
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Feb 1989
Decision
73d
Days
Class 2
Risk

K885028 is an FDA 510(k) clearance for the COULTER 5P CONTROL. Classified as Counter, Differential Cell (product code GKZ), Class II - Special Controls.

Submitted by Coulter Electronics, Inc. (Hialeah, US). The FDA issued a Cleared decision on February 16, 1989 after a review of 73 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.

FDA 510(k) Submission Details - K885028

510(k) Number K885028 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 1988
Decision Date February 16, 1989
Days to Decision 73 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
40d faster than avg
Panel avg: 113d · This submission: 73d
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 380
Devices cleared under the same product code (GKZ) and FDA review panel - the closest regulatory comparables to K885028.
QBC III CENTRIFUGAL HEMATOLOGY SYSTEM
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CELL-DYN 3000 MULTI-PARAMETER HEMATOLOGY ANALYER
K890491 · Abbott Diagnostics · Apr 1989
COULTER CLONE T3 MONOCLONAL ANTIBODY
K883710 · Coulter Immunology · Feb 1989
COULTER CLONE T1 MONOCLONAL ANTIBODY
K883753 · Coulter Immunology · Feb 1989
COULTER CLONE B4 MONOCLONAL ANTIBODY
K884020 · Coulter Immunology · Feb 1989
K885028 · COULTER 5P CONTROL
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