Cleared Traditional

K870196 - PCTE MICROPOROUS MEMBRANE FILTER (FDA 510(k) Clearance)

Class I Pathology device.

K870196 · Poretics Corp. · Pathology device
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May 1987
Decision
112d
Days
Class 1
Risk

K870196 is an FDA 510(k) clearance for the PCTE MICROPOROUS MEMBRANE FILTER. Classified as Filters, Cell Collection, Tissue Processing (product code KET), Class I - General Controls.

Submitted by Poretics Corp. (Livermore, US). The FDA issued a Cleared decision on May 12, 1987 after a review of 112 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Pathology review framework, consistent with the majority of Class II 510(k) submissions.

View all Poretics Corp. devices

Submission Details

510(k) Number K870196 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 20, 1987
Decision Date May 12, 1987
Days to Decision 112 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d slower than avg
Panel avg: 77d · This submission: 112d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KET Filters, Cell Collection, Tissue Processing
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.