Cleared Traditional

K800325 - VOLU-SOL HISTO./CYTO. STAIN MOD. #EA65 (FDA 510(k) Clearance)

Class I Pathology device.

K800325 · Volu Sol Medical Industries · Pathology device
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Feb 1980
Decision
14d
Days
Class 1
Risk

K800325 is an FDA 510(k) clearance for the VOLU-SOL HISTO./CYTO. STAIN MOD. #EA65. Classified as Stain, Papanicolau (product code HZJ), Class I - General Controls.

Submitted by Volu Sol Medical Industries (Mchenry, US). The FDA issued a Cleared decision on February 26, 1980 after a review of 14 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 Volu Sol Medical Industries devices

Submission Details

510(k) Number K800325 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 1980
Decision Date February 26, 1980
Days to Decision 14 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 77d · This submission: 14d
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.