Cleared Traditional

K861270 - BLUE RIBBON PARAFFIN INFILTRATION/EMBED...

K861270 is the FDA 510(k) clearance for BLUE RIBBON PARAFFIN INFILTRATION/EMBED... by Surgipath Medical Industries, Inc.. It is a Class 1 Pathology device (product code KEO) cleared through the Traditional 510(k) pathway after a 7-day FDA review.

K861270 · Surgipath Medical Industries, Inc. · Pathology device
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Apr 1986
Decision
7d
Days
Class 1
Risk

K861270 is an FDA 510(k) clearance for the BLUE RIBBON PARAFFIN INFILTRATION/EMBEDDING MED.. Classified as Formulations, Paraffin, All (product code KEO), Class I - General Controls.

Submitted by Surgipath Medical Industries, Inc. (Grayslake, US). The FDA issued a Cleared decision on April 11, 1986 after a review of 7 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 Surgipath Medical Industries, Inc. devices

Submission Details

510(k) Number K861270 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 1986
Decision Date April 11, 1986
Days to Decision 7 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 77d · This submission: 7d
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 K861270.
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