Cleared Traditional

K843506 - LKB 2189 ULTROPROCESSOR

K843506 is the FDA 510(k) clearance for LKB 2189 ULTROPROCESSOR by Lkb Instruments, Inc.. It is a Class 1 Pathology device (product code IEO) cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K843506 · Lkb Instruments, Inc. · Pathology device
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Nov 1984
Decision
85d
Days
Class 1
Risk

K843506 is an FDA 510(k) clearance for the LKB 2189 ULTROPROCESSOR. Classified as Processor, Tissue, Automated (product code IEO), Class I - General Controls.

Submitted by Lkb Instruments, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 30, 1984 after a review of 85 days - a notably fast clearance cycle.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 864.3875 - the FDA pathology 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 Lkb Instruments, Inc. devices

Submission Details

510(k) Number K843506 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 1984
Decision Date November 30, 1984
Days to Decision 85 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
8d slower than avg
Panel avg: 77d · This submission: 85d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code IEO Processor, Tissue, Automated
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.3875
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - IEO Processor, Tissue, Automated

Devices cleared under the same product code (IEO) and FDA review panel - the closest regulatory comparables to K843506.
AUTOTECHNICON V TISSUE PROCESS SYS
K834599 · Technicon Instruments Corp. · Feb 1984
TISSUE-TEK V.I.P. 100/200
K831313 · Miles Laboratories, Inc. · Jul 1983
TISSUE-TEK III MINI-RAPID PROCESSOR
K801427 · Miles Laboratories, Inc. · Jul 1980
TISSUE-TEK III V.I.P.
K771308 · Miles Laboratories, Inc. · Aug 1977
HISTO-TEK W/ AUTOMATIC COVERSLIPPER
K761062 · Miles Laboratories, Inc. · Mar 1977