Cleared Traditional

K810568 - PARAFFIN EMBEDDING MEDIUM (FDA 510(k) Clearance)

Class I Radiology device.

K810568 · Surgipath Medical Industries, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1981
Decision
14d
Days
Class 1
Risk

K810568 is an FDA 510(k) clearance for the PARAFFIN EMBEDDING MEDIUM. Classified as Formulations, Paraffin, All (product code KEO), Class I - General Controls.

Submitted by Surgipath Medical Industries, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 17, 1981 after a review of 14 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 864.4010 - the FDA radiology and imaging software oversight 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 K810568 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 1981
Decision Date March 17, 1981
Days to Decision 14 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
93d faster than avg
Panel avg: 107d · This submission: 14d
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.