Cleared Traditional

K801143 - VOLU-SOL URINARY DICHROME STAIN (FDA 510(k) Clearance)

Class I Pathology device.

K801143 · Volu Sol Medical Industries · Pathology device
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May 1980
Decision
12d
Days
Class 1
Risk

K801143 is an FDA 510(k) clearance for the VOLU-SOL URINARY DICHROME STAIN. Classified as Alcian Blue (product code IDA), Class I - General Controls.

Submitted by Volu Sol Medical Industries (Mchenry, US). The FDA issued a Cleared decision on May 30, 1980 after a review of 12 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 K801143 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 1980
Decision Date May 30, 1980
Days to Decision 12 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
65d faster than avg
Panel avg: 77d · This submission: 12d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code IDA Alcian Blue
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.