Cleared Traditional

K791041 - HEMATRAK ABNORMAL RECOGNITION

K791041 is an FDA 510(k) clearance for HEMATRAK ABNORMAL RECOGNITION, manufactured by Geometric Data, Div. Smithkline Corp.. The device is a Class 2 Hematology device with product code GKZ cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K791041 · Geometric Data, Div. Smithkline Corp. · Hematology device
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Sep 1979
Decision
91d
Days
Class 2
Risk

K791041 is an FDA 510(k) clearance for the HEMATRAK ABNORMAL RECOGNITION. Classified as Counter, Differential Cell (product code GKZ), Class II - Special Controls.

Submitted by Geometric Data, Div. Smithkline Corp. (Mchenry, US). The FDA issued a Cleared decision on September 4, 1979 after a review of 91 days - within the typical 510(k) review window.

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 Geometric Data, Div. Smithkline Corp. devices

FDA 510(k) Submission Details - K791041

510(k) Number K791041 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 1979
Decision Date September 04, 1979
Days to Decision 91 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
22d faster than avg
Panel avg: 113d · This submission: 91d
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 K791041.
ADD OF RETICULOCYTE COUNT/CAPABILITIES
K800533 · Abbott Laboratories · Apr 1980
TECHNICON C/90 SYSTEM
K800121 · Technicon Instruments Corp. · Feb 1980
COULTER DIFF3 SYS. (COULTER #7400003)
K791903 · Coulter Electronics, Inc. · Oct 1979
HEMATRAK MODEL 480
K790816 · Geometric Data, Div. Smithkline Corp. · Jul 1979
CONTEXT FILTER
K791108 · Geometric Data, Div. Smithkline Corp. · Jul 1979
PLATELETS/CU MM
K780577 · Geometric Data, Div. Smithkline Corp. · May 1978