Cleared Traditional

K791108 - CONTEXT FILTER

K791108 is an FDA 510(k) clearance for CONTEXT FILTER, 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 33-day FDA review.

K791108 · Geometric Data, Div. Smithkline Corp. · Hematology device
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Jul 1979
Decision
33d
Days
Class 2
Risk

K791108 is an FDA 510(k) clearance for the CONTEXT FILTER. 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 July 17, 1979 after a review of 33 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 Geometric Data, Div. Smithkline Corp. devices

FDA 510(k) Submission Details - K791108

510(k) Number K791108 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 1979
Decision Date July 17, 1979
Days to Decision 33 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
80d faster than avg
Panel avg: 113d · This submission: 33d
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 K791108.
COULTER DIFF3 SYS. (COULTER #7400003)
K791903 · Coulter Electronics, Inc. · Oct 1979
HEMATRAK ABNORMAL RECOGNITION
K791041 · Geometric Data, Div. Smithkline Corp. · Sep 1979
HEMATRAK MODEL 480
K790816 · Geometric Data, Div. Smithkline Corp. · Jul 1979
PLATELETS/CU MM
K780577 · Geometric Data, Div. Smithkline Corp. · May 1978
HEMATRAK RBC MORPHOLOGY
K761207 · Geometric Data, Div. Smithkline Corp. · Oct 1977
AUTO DIFFERENTIAL CELL COUNTER SYSTEM
K770244 · Abbott Laboratories · Aug 1977