Cleared Traditional

K853938 - LX 300 TISSUE PROCESSOR (FDA 510(k) Clearance)

Class I Pathology device.

K853938 · Innovative Medical Systems, Inc. · Pathology device
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Oct 1985
Decision
16d
Days
Class 1
Risk

K853938 is an FDA 510(k) clearance for the LX 300 TISSUE PROCESSOR. Classified as Processor, Tissue, Automated (product code IEO), Class I - General Controls.

Submitted by Innovative Medical Systems, Inc. (Ivyland, US). The FDA issued a Cleared decision on October 10, 1985 after a review of 16 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 Innovative Medical Systems, Inc. devices

Submission Details

510(k) Number K853938 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 1985
Decision Date October 10, 1985
Days to Decision 16 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 77d · This submission: 16d
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.