Cleared Traditional

K893772 - TISSUE EMBEDDING MEDIUM

K893772 is the FDA 510(k) clearance for TISSUE EMBEDDING MEDIUM by Stephens Scientific. It is a Class 1 Pathology device (product code KEO) cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K893772 · Stephens Scientific · Pathology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

View all Stephens Scientific devices

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.

Regulatory Peers - KEO Formulations, Paraffin, All

Devices cleared under the same product code (KEO) and FDA review panel - the closest regulatory comparables to K893772.
MICRO THIN* PARAFFIN
K862223 · Richard-Allan Medical Ind., Inc. · Jun 1986
PARAPLAST EXTRA TISSUE EMBEDDING MED.
K842053 · Sherwood Medical Co. · Jun 1984
TECHNICON PARACUT
K833071 · Technicon Instruments Corp. · Oct 1983
HISTOLOGICAL EMBEDDING MEDIA
K803241 · Miles Laboratories, Inc. · Jan 1981
SORVALL EMBEDDING MEDIUM
K760602 · E.I. Dupont DE Nemours & Co., Inc. · Sep 1976