Cleared Traditional

K893772 - TISSUE EMBEDDING MEDIUM (FDA 510(k) Clearance)

Class I Pathology device.

K893772 · Stephens Scientific · Pathology device
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Jun 1989
Decision
31d
Days
Class 1
Risk

K893772 is an FDA 510(k) clearance for the TISSUE EMBEDDING MEDIUM. Classified as Formulations, Paraffin, All (product code KEO), Class I - General Controls.

Submitted by Stephens Scientific (Denville, US). The FDA issued a Cleared decision on June 22, 1989 after a review of 31 days - a notably fast clearance cycle.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 864.4010 - 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.

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Submission Details

510(k) Number K893772 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 1989
Decision Date June 22, 1989
Days to Decision 31 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 77d · This submission: 31d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KEO Formulations, Paraffin, All
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.4010
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.