Cleared Traditional

K802094 - ORTHO SPECTRUM

K802094 is an FDA 510(k) clearance for ORTHO SPECTRUM, manufactured by Ortho Instruments. The device is a Class 2 Hematology device with product code GKL cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K802094 · Ortho Instruments · Hematology device
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Oct 1980
Decision
38d
Days
Class 2
Risk

K802094 is an FDA 510(k) clearance for the ORTHO SPECTRUM. Classified as Counter, Cell, Automated (particle Counter) (product code GKL), Class II - Special Controls.

Submitted by Ortho Instruments (Walker, US). The FDA issued a Cleared decision on October 10, 1980 after a review of 38 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5200 - 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 - K802094

510(k) Number K802094 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 02, 1980
Decision Date October 10, 1980
Days to Decision 38 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
75d faster than avg
Panel avg: 113d · This submission: 38d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GKL Device Classification - Class 2, Special Controls

Product Code GKL Counter, Cell, Automated (particle Counter)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5200
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 - GKL Counter, Cell, Automated (particle Counter)

All 128
Devices cleared under the same product code (GKL) and FDA review panel - the closest regulatory comparables to K802094.
CELL DYN 800 HEMATOLOGY ANALYZER
K803218 · Abbott Diagnostics · Jun 1981
SERIES 810 PLATELET ANALYZER
K803128 · J.T. Baker Chemical Co. · Apr 1981
PLATELET COUNTING KIT
K802636 · Streck Laboratories, Inc. · Dec 1980
LEUKOCYTE VOL. ANALYSIS APPARATUS
K802208 · Coulter Electronics, Inc. · Sep 1980
ORTHO AUTOMATED CELL COUNTER
K801545 · Ortho Instruments · Sep 1980
TECHNICON H6000 HEMATOLOGY SYSTEM
K801155 · Technicon Instruments Corp. · Jun 1980
K802094 · ORTHO SPECTRUM
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