Cleared Traditional

K821540 - HEMATOXYLIN II

K821540 is the FDA 510(k) clearance for HEMATOXYLIN II by Volu Sol Medical Industries. It is a Class 1 Pathology device (product code HYJ) cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K821540 · Volu Sol Medical Industries · Pathology device
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Jun 1982
Decision
17d
Days
Class 1
Risk

K821540 is an FDA 510(k) clearance for the HEMATOXYLIN II. Classified as Hematoxylin (product code HYJ), Class I - General Controls.

Submitted by Volu Sol Medical Industries (Mchenry, US). The FDA issued a Cleared decision on June 10, 1982 after a review of 17 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 K821540 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 24, 1982
Decision Date June 10, 1982
Days to Decision 17 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 77d · This submission: 17d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HYJ Hematoxylin
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 - HYJ Hematoxylin

All 7
Devices cleared under the same product code (HYJ) and FDA review panel - the closest regulatory comparables to K821540.
GILL HEMATOXYLIN STAIN
K842741 · E K Ind., Inc. · Aug 1984
HEMATOXYLIN STAIN SOLUTION
K822352 · Fisher Scientific Co., LLC · Aug 1982
HEMATOXYLIN I
K821533 · Volu Sol Medical Industries · Jun 1982
HEMATOXYLIN III
K821541 · Volu Sol Medical Industries · Jun 1982
HEMATOXYLIN STAIN
K821320 · Sigma Chemical Co. · Jun 1982
HEMATOXYLIN SOLUTION
K821062 · Sigma Chemical Co. · Apr 1982