Cleared Traditional

K851306 - COBE SYSTEM 3

K851306 is the FDA 510(k) clearance for COBE SYSTEM 3 by Cobe Laboratories, Inc.. It is a Class 2 Gastroenterology & Urology device (product code FKP) cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K851306 · Cobe Laboratories, Inc. · Gastroenterology & Urology device
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Jun 1985
Decision
72d
Days
Class 2
Risk

K851306 is an FDA 510(k) clearance for the COBE SYSTEM 3. Classified as System, Dialysate Delivery, Single Patient (product code FKP), Class II - Special Controls.

Submitted by Cobe Laboratories, Inc. (Lakewood, US). The FDA issued a Cleared decision on June 12, 1985 after a review of 72 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 Cobe Laboratories, Inc. devices

Submission Details

510(k) Number K851306 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 1985
Decision Date June 12, 1985
Days to Decision 72 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
58d faster than avg
Panel avg: 130d · This submission: 72d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FKP System, Dialysate Delivery, Single Patient
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 - FKP System, Dialysate Delivery, Single Patient

All 20
Devices cleared under the same product code (FKP) and FDA review panel - the closest regulatory comparables to K851306.
GAMBRO FLUID CONTROL MONITOR FCM 10-1
K864094 · Gambro, Inc. · Nov 1986
GAMBRO BICARBONATE MONITOR BCM 10-2
K864083 · Gambro, Inc. · Nov 1986
HD-SECURA HEMADIALYSIS MACHINE
K854367 · Organon Teknika Corp. · Dec 1985
BSM 2000 DIALYSIS MACHINE - MODIFIED
K850569 · Organon Teknika Corp. · Mar 1985
B-D DRAKE WILLOCK #7000 SERIES ULTRAF
K811591 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jul 1981
DIALYSIS CONTROL UNIT-CENTRY 2000
K802250 · Cobe Laboratories, Inc. · Dec 1980