Cleared Traditional

K882579 - HEMATRAK(R) MODEL 590

K882579 is an FDA 510(k) clearance for HEMATRAK MODEL 590, manufactured by Priority Service Systems. 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.

K882579 · Priority Service Systems · Hematology device
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Sep 1988
Decision
76d
Days
Class 2
Risk

K882579 is an FDA 510(k) clearance for the HEMATRAK(R) MODEL 590. Classified as Counter, Differential Cell (product code GKZ), Class II - Special Controls.

Submitted by Priority Service Systems (Atlanta, US). The FDA issued a Cleared decision on September 7, 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 Priority Service Systems devices

FDA 510(k) Submission Details - K882579

510(k) Number K882579 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 1988
Decision Date September 07, 1988
Days to Decision 76 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
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 305
Devices cleared under the same product code (GKZ) and FDA review panel - the closest regulatory comparables to K882579.
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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