Cleared Traditional

K862015 - O.2 MICRON INFECTION RESISTANT HYDROPHOBIC FILTER

K862015 is an FDA 510(k) clearance for O.2 MICRON INFECTION RESISTANT HYDROPHO..., manufactured by Bipore, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FIB cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K862015 · Bipore, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K862015

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
76d faster than avg
Panel avg: 131d · This submission: 55d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FIB Device Classification - Class 2, Special Controls

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.

Regulatory Peers - FIB Protector, Transducer, Dialysis

All 34
Devices cleared under the same product code (FIB) and FDA review panel - the closest regulatory comparables to K862015.
DA-46 FLUID BARRIER
K891752 · Akcess Medical Products, Inc. · Apr 1989
HYDROPHOBIC #6194418/HYDRAPHILIC #6104418 FILTERS
K870394 · Clinical Connections, Inc. · Mar 1987
MEDIFLEX TRANSDUCER PROTECTOR
K863496 · Mediflex Intl. · Sep 1986
OMNIMED SUPERIOR TRANSDUCER PROTECTOR
K851734 · Omni Intl., Inc. · May 1985
TRANDUCER PROTECTOR
K851428 · Galvin Industries, Inc. · May 1985
GAMBRO PRESSURE MONITOR GUARDS
K851230 · Gambro, Inc. · Apr 1985
K862015 · O.2 MICRON INFECTION RESISTANT HYDROPHOBIC FILTER
Download PDF Bipore, Inc.