Cleared Traditional

K812086 - EA 65

K812086 is the FDA 510(k) clearance for EA 65 by Surgipath. It is a Class 1 Pathology device (product code HZJ) cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K812086 · Surgipath · Pathology device
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Aug 1981
Decision
22d
Days
Class 1
Risk

K812086 is an FDA 510(k) clearance for the EA 65. 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 K812086 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.

Regulatory Peers - HZJ Stain, Papanicolau

All 8
Devices cleared under the same product code (HZJ) and FDA review panel - the closest regulatory comparables to K812086.
PAP STAIN EA-50
K842738 · E K Ind., Inc. · Aug 1984
PAPANICOLAOU STAIN SYS HT40
K840054 · Sigma Chemical Co. · Feb 1984
VOLU-SOL GILLS EA
K822035 · Volu Sol Medical Industries · Aug 1982
VOLU-SOL EA-50 STAIN
K800322 · Volu Sol Medical Industries · Feb 1980
VOLU-SOL HISTO./CYTO. STAIN MOD. #EA65
K800325 · Volu Sol Medical Industries · Feb 1980