Cleared Traditional

K920312 - NEW COBE CARDIOPLEGIA SYSTEM

K920312 is an FDA 510(k) clearance for NEW COBE CARDIOPLEGIA SYSTEM, manufactured by Cobe Cardiovascular, Inc.. The device is a Class 2 Cardiovascular device with product code DTN cleared through the Traditional 510(k) pathway after a 252-day FDA review.

K920312 · Cobe Cardiovascular, Inc. · Cardiovascular device
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Oct 1992
Decision
252d
Days
Class 2
Risk

K920312 is an FDA 510(k) clearance for the NEW COBE CARDIOPLEGIA SYSTEM. Classified as Reservoir, Blood, Cardiopulmonary Bypass (product code DTN), Class II - Special Controls.

Submitted by Cobe Cardiovascular, Inc. (Arvada, US). The FDA issued a Cleared decision on October 1, 1992 after a review of 252 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4400 - the FDA cardiovascular device oversight 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 Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Cobe Cardiovascular, Inc. devices

FDA 510(k) Submission Details - K920312

510(k) Number K920312 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 1992
Decision Date October 01, 1992
Days to Decision 252 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
127d slower than avg
Panel avg: 125d · This submission: 252d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DTN Device Classification - Class 2, Special Controls

Product Code DTN Reservoir, Blood, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4400
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - DTN Reservoir, Blood, Cardiopulmonary Bypass

All 134
Devices cleared under the same product code (DTN) and FDA review panel - the closest regulatory comparables to K920312.
ELECTROMEDICS EL-SERIES CARDIOTOMY RESERVOIR
K926250 · Electromedics, Inc. · Feb 1993
VENOUS RESERVOIR W/CARDIOTOMY FILTER
K915573 · Baxter Healthcare Corp · Dec 1992
MVR COLLAPSIBLE VENOUS RESERVOIR BAG
K920774 · Medtronic Vascular · Oct 1992
AUTOTRANSFUSION BLOOD COLLECTION RESERVOIR
K915737 · Electromedics, Inc. · Sep 1992
BLOOD CARDIOPLEGIA HEAT EXCHANGER, MODEL #HE-30
K913956 · Bentley Laboratories, Inc. · Jan 1992
VENOUS RESERVOIR BAG MODEL NO. BMR-250(TM)
K913692 · Bentley Laboratories, Inc. · Nov 1991