Cleared Traditional

K820100 - FROSTED GLASS SLIDES

K820100 is an FDA 510(k) clearance for FROSTED GLASS SLIDES, manufactured by Stan-Pak Ent.. The device is a Class 1 Pathology device with product code KEW cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K820100 · Stan-Pak Ent. · Pathology device
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Mar 1982
Decision
50d
Days
Class 1
Risk

K820100 is an FDA 510(k) clearance for the FROSTED GLASS SLIDES. Classified as Slides, Microscope (product code KEW), Class I - General Controls.

Submitted by Stan-Pak Ent. (Mchenry, US). The FDA issued a Cleared decision on March 4, 1982 after a review of 50 days - a notably fast clearance cycle.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 864.3010 - 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 Stan-Pak Ent. devices

FDA 510(k) Submission Details - K820100

510(k) Number K820100 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 13, 1982
Decision Date March 04, 1982
Days to Decision 50 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
27d faster than avg
Panel avg: 77d · This submission: 50d
Pathway characteristics
Predicate-based equivalence.

KEW Device Classification - Class 1, General Controls

Product Code KEW Slides, Microscope
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.3010
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.