Cleared Traditional

K782050 - PRINTER, TEK PRO TEK TALLY II

K782050 is an FDA 510(k) clearance for PRINTER, manufactured by Tekpro. The device is a Class 2 Hematology device with product code GKZ cleared through the Traditional 510(k) pathway after a 26-day FDA review.

K782050 · Tekpro · Hematology device
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Jan 1979
Decision
26d
Days
Class 2
Risk

K782050 is an FDA 510(k) clearance for the PRINTER, TEK PRO TEK TALLY II. Classified as Counter, Differential Cell (product code GKZ), Class II - Special Controls.

Submitted by Tekpro (Mchenry, US). The FDA issued a Cleared decision on January 3, 1979 after a review of 26 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.

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FDA 510(k) Submission Details - K782050

510(k) Number K782050 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 1978
Decision Date January 03, 1979
Days to Decision 26 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
87d faster than avg
Panel avg: 113d · This submission: 26d
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 310
Devices cleared under the same product code (GKZ) and FDA review panel - the closest regulatory comparables to K782050.
HEMATRAK ABNORMAL RECOGNITION
K791041 · Geometric Data, Div. Smithkline Corp. · Sep 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
HEMATRAK RBC MORPHOLOGY
K761207 · Geometric Data, Div. Smithkline Corp. · Oct 1977
AUTO DIFFERENTIAL CELL COUNTER SYSTEM
K770244 · Abbott Laboratories · Aug 1977