Cleared Traditional

K924590 - MICROWAVE AUTOMATED TISSUE PROCESSOR

K924590 is the FDA 510(k) clearance for MICROWAVE AUTOMATED TISSUE PROCESSOR by Innovative Medical Systems, Inc.. It is a Class 1 Pathology device (product code IEO) cleared through the Traditional 510(k) pathway after a 110-day FDA review.

K924590 · Innovative Medical Systems, Inc. · Pathology device
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Dec 1992
Decision
110d
Days
Class 1
Risk

K924590 is an FDA 510(k) clearance for the MICROWAVE AUTOMATED 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 December 29, 1992 after a review of 110 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Pathology review framework, consistent with the majority of Class II 510(k) submissions.

View all Innovative Medical Systems, Inc. devices

Submission Details

510(k) Number K924590 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 10, 1992
Decision Date December 29, 1992
Days to Decision 110 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
33d slower than avg
Panel avg: 77d · This submission: 110d
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 K924590.
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K771308 · Miles Laboratories, Inc. · Aug 1977
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K761062 · Miles Laboratories, Inc. · Mar 1977