Cleared Traditional

K870196 - PCTE MICROPOROUS MEMBRANE FILTER

K870196 is an FDA 510(k) clearance for PCTE MICROPOROUS MEMBRANE FILTER, manufactured by Poretics Corp.. The device is a Class 1 Pathology device with product code KET cleared through the Traditional 510(k) pathway after a 112-day FDA review.

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.

FDA 510(k) Submission Details - K870196

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
34d slower than avg
Panel avg: 78d · This submission: 112d
Pathway characteristics
Predicate-based equivalence.

KET Device Classification - Class 1, General Controls

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.

Regulatory Peers - KET Filters, Cell Collection, Tissue Processing

Devices cleared under the same product code (KET) and FDA review panel - the closest regulatory comparables to K870196.
DISPOSABLE STERILE SYRINGE FILTERS
K875122 · Corning Medical & Scientific · Jan 1988
CORNING DISPOSAL STERILE FILTER SYSTEM-NYLON
K844671 · Corning Medical & Scientific · Feb 1985
DISPOSABLE SYRINGE FILTERS
K840556 · Corning Medical & Scientific · Mar 1984
STERILIZATION PROCESS/OUTERWRAP
K792633 · Procter & Gamble Mfg. Co. · Jan 1980