Cleared Traditional

K864831 - COBE CENTRYSYSTEM 145E

K864831 is the FDA 510(k) clearance for COBE CENTRYSYSTEM 145E by Cobe Laboratories, Inc.. It is a Class 2 Gastroenterology & Urology device (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

Submission Details

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.

Device Classification

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 51
Devices cleared under the same product code (FJI) and FDA review panel - the closest regulatory comparables to K864831.
GAMBRO ALWALL GFE 11 & 15 HOLLOW FIBER DIALYZERS
K880083 · Gambro, Inc. · Jan 1988
CAPILLARY FLOW DIALYZERS MODELS ST-12 & ST-15
K871471 · Travenol Laboratories, S.A. · Jun 1987
CAPILLARY FLOW DIALYZERS
K870169 · Travenol Laboratories, S.A. · Apr 1987
CLIRANS TAF HOLLOW FIBER DIALYZER
K854280 · Terumo Medical Corp. · Dec 1985
DIALYZER, CAPILLARY, HOLLOW FIBER
K853591 · Organon Teknika Corp. · Sep 1985
CLIRANS HOLLOW FIBER DIALYZERS
K820524 · Terumo Medical Corp. · Jul 1982