Cleared Traditional

K864831 - COBE CENTRYSYSTEM 145E,160E,175E,190E DIALYZERS

K864831 is an FDA 510(k) clearance for COBE CENTRYSYSTEM 145E, manufactured by Cobe Laboratories, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FJI cleared through the Traditional 510(k) pathway after a 108-day FDA review.

K864831 · Cobe Laboratories, Inc. · Gastroenterology & Urology device
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Mar 1987
Decision
108d
Days
Class 2
Risk

K864831 is an FDA 510(k) clearance for the COBE CENTRYSYSTEM 145E,160E,175E,190E DIALYZERS. Classified as Dialyzer, Capillary, Hollow Fiber (product code FJI), Class II - Special Controls.

Submitted by Cobe Laboratories, Inc. (Lakewood, US). The FDA issued a Cleared decision on March 27, 1987 after a review of 108 days - within the typical 510(k) review window.

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

View all Cobe Laboratories, Inc. devices

FDA 510(k) Submission Details - K864831

510(k) Number K864831 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 1986
Decision Date March 27, 1987
Days to Decision 108 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
22d faster than avg
Panel avg: 130d · This submission: 108d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FJI Device Classification - Class 2, Special Controls

Product Code FJI Dialyzer, Capillary, Hollow Fiber
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 - FJI Dialyzer, Capillary, Hollow Fiber

All 105
Devices cleared under the same product code (FJI) and FDA review panel - the closest regulatory comparables to K864831.
FRESENIUS HEMOFLOW F6 AND F8
K870725 · Seratronics, Inc. · May 1987
CAPILLARY FLOW DIALYZERS
K870169 · Travenol Laboratories, S.A. · Apr 1987
CAPILLARY FLOW HOLLOW FIBER DIALYZERS
K863044 · National Medical Care, Medical Products Div., Inc. · Mar 1987
DISSCAP 80E, 110E, 140E, 160E
K863592 · Hospal Medical Corp. · Sep 1986
TORAY FILTRYZER DIALYZER, B1-2.0.
K862693 · National Medical Care, Medical Products Div., Inc. · Jul 1986
ADVANCED PERFORM HOLLOW FIBER DIALYZER, 01-9751-7
K861536 · National Medical Care, Medical Products Div., Inc. · Jul 1986