Cleared Traditional

K810758 - GILL'S HEMATOXYLIN #1 (FDA 510(k) Clearance)

Class I Pathology device.

K810758 · Surgipath · Pathology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1981
Decision
25d
Days
Class 1
Risk

K810758 is an FDA 510(k) clearance for the GILL'S HEMATOXYLIN #1. Classified as Hematoxylin (product code HYJ), Class I - General Controls.

Submitted by Surgipath (Mchenry, US). The FDA issued a Cleared decision on April 14, 1981 after a review of 25 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 K810758 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 1981
Decision Date April 14, 1981
Days to Decision 25 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
52d faster than avg
Panel avg: 77d · This submission: 25d
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.