Cleared Traditional

K810323 - ACRYTOL, MOUNTING MEDIUM

K810323 is an FDA 510(k) clearance for ACRYTOL, manufactured by Surgipath. The device is a Class 1 Pathology device with product code KEP cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K810323 · Surgipath · Pathology device
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Mar 1981
Decision
28d
Days
Class 1
Risk

K810323 is an FDA 510(k) clearance for the ACRYTOL, MOUNTING MEDIUM. Classified as Media, Mounting, Oil Soluble (product code KEP), Class I - General Controls.

Submitted by Surgipath (Mchenry, US). The FDA issued a Cleared decision on March 6, 1981 after a review of 28 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.

FDA 510(k) Submission Details - K810323

510(k) Number K810323 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 1981
Decision Date March 06, 1981
Days to Decision 28 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 78d · This submission: 28d
Pathway characteristics
Predicate-based equivalence.

KEP Device Classification - Class 1, General Controls

Product Code KEP Media, Mounting, Oil Soluble
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.

K810323 · ACRYTOL, MOUNTING MEDIUM
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