Cleared Traditional

K843505 - LKB 2230 ROTARY ONE (FDA 510(k) Clearance)

Class I Pathology device.

K843505 · Lkb Instruments, Inc. · Pathology device
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Nov 1984
Decision
85d
Days
Class 1
Risk

K843505 is an FDA 510(k) clearance for the LKB 2230 ROTARY ONE. Classified as Microtome, Rotary (product code IDO), Class I - General Controls.

Submitted by Lkb Instruments, Inc. (Gaithersburg, 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 864.3010 - 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 K843505 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
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 IDO Microtome, Rotary
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.3010
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.