Cleared Traditional

K811826 - EOSIN Y

K811826 is an FDA 510(k) clearance for EOSIN Y, manufactured by Surgipath. The device is a Class 1 Pathology device with product code HYB cleared through the Traditional 510(k) pathway after a 11-day FDA review.

K811826 · Surgipath · Pathology device
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Jul 1981
Decision
11d
Days
Class 1
Risk

K811826 is an FDA 510(k) clearance for the EOSIN Y. Classified as Eosin Y (product code HYB), Class I - General Controls.

Submitted by Surgipath (Mchenry, US). The FDA issued a Cleared decision on July 10, 1981 after a review of 11 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.

FDA 510(k) Submission Details - K811826

510(k) Number K811826 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 29, 1981
Decision Date July 10, 1981
Days to Decision 11 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 78d · This submission: 11d
Pathway characteristics
Predicate-based equivalence.

HYB Device Classification - Class 1, General Controls

Product Code HYB Eosin Y
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.

K811826 · EOSIN Y
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