Cleared Traditional

O.2 MICRON INFECTION RESISTANT HYDROPHOBIC FILTER (K862015) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K862015 · Bipore, Inc. · Gastroenterology & Urology device
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Jul 1986
Decision
55d
Days
Class 2
Risk

K862015 is an FDA 510(k) clearance for the O.2 MICRON INFECTION RESISTANT HYDROPHOBIC FILTER. Classified as Protector, Transducer, Dialysis (product code FIB), Class II - Special Controls.

Submitted by Bipore, Inc. (Demarest, US). The FDA issued a Cleared decision on July 22, 1986 after a review of 55 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5820 - the FDA gastroenterology and urology 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 Bipore, Inc. devices

Submission Details

510(k) Number K862015 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 1986
Decision Date July 22, 1986
Days to Decision 55 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
75d faster than avg
Panel avg: 130d · This submission: 55d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FIB Protector, Transducer, Dialysis
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5820
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.