Cleared Traditional

K802690 - ULTRAPAK CAT. #100-0251 (FDA 510(k) Clearance)

Class I Pathology device.

K802690 · Occumedics, Inc. · Pathology device
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Jan 1981
Decision
73d
Days
Class 1
Risk

K802690 is an FDA 510(k) clearance for the ULTRAPAK CAT. #100-0251. Classified as Glenner's Stain (product code HYG), Class I - General Controls.

Submitted by Occumedics, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 8, 1981 after a review of 73 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 Occumedics, Inc. devices

Submission Details

510(k) Number K802690 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 27, 1980
Decision Date January 08, 1981
Days to Decision 73 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
4d faster than avg
Panel avg: 77d · This submission: 73d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HYG Glenner's Stain
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.