Cleared Traditional

PULLEN POCKET SCOPE (K802818) - FDA 510(k) Clearance

Class I Microbiology device.

K802818 · P.A. Research Corp. · Microbiology device
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Apr 1981
Decision
161d
Days
Class 1
Risk

K802818 is an FDA 510(k) clearance for the PULLEN POCKET SCOPE. Classified as Light, Microscope (product code IBJ), Class I - General Controls.

Submitted by P.A. Research Corp. (Mchenry, US). The FDA issued a Cleared decision on April 17, 1981 after a review of 161 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 864.3600 - the FDA microbiology 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all P.A. Research Corp. devices

Submission Details

510(k) Number K802818 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 1980
Decision Date April 17, 1981
Days to Decision 161 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
59d slower than avg
Panel avg: 102d · This submission: 161d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code IBJ Light, Microscope
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.3600
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.