Cleared Traditional

K812087 - EA 50 (FDA 510(k) Clearance)

Class I Pathology device.

K812087 · Surgipath · Pathology device
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Aug 1981
Decision
22d
Days
Class 1
Risk

K812087 is an FDA 510(k) clearance for the EA 50. Classified as Stain, Papanicolau (product code HZJ), Class I - General Controls.

Submitted by Surgipath (Mchenry, US). The FDA issued a Cleared decision on August 13, 1981 after a review of 22 days - a notably fast clearance cycle.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 864.1850 - 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 devices

Submission Details

510(k) Number K812087 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 1981
Decision Date August 13, 1981
Days to Decision 22 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
55d faster than avg
Panel avg: 77d · This submission: 22d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HZJ Stain, Papanicolau
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.1850
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.