Cleared Traditional

K902437 - COBE CARDIOTOMY RESERVOIR WITH OR WITHOUT FILTER

K902437 is an FDA 510(k) clearance for COBE CARDIOTOMY RESERVOIR WITH OR WITHO..., manufactured by Cobe Laboratories, Inc.. The device is a Class 2 Cardiovascular device with product code DTP cleared through the Traditional 510(k) pathway after a 196-day FDA review.

K902437 · Cobe Laboratories, Inc. · Cardiovascular device
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Dec 1990
Decision
196d
Days
Class 2
Risk

K902437 is an FDA 510(k) clearance for the COBE CARDIOTOMY RESERVOIR WITH OR WITHOUT FILTER. Classified as Defoamer, Cardiopulmonary Bypass (product code DTP), Class II - Special Controls.

Submitted by Cobe Laboratories, Inc. (Arvada, US). The FDA issued a Cleared decision on December 17, 1990 after a review of 196 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4230 - 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 Laboratories, Inc. devices

FDA 510(k) Submission Details - K902437

510(k) Number K902437 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 1990
Decision Date December 17, 1990
Days to Decision 196 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
71d slower than avg
Panel avg: 125d · This submission: 196d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DTP Device Classification - Class 2, Special Controls

Product Code DTP Defoamer, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4230
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 - DTP Defoamer, Cardiopulmonary Bypass

All 31
Devices cleared under the same product code (DTP) and FDA review panel - the closest regulatory comparables to K902437.
SARNS NON-FILTERED VENOUS RESERVOIR
K912915 · 3M Health Care, Ltd. · Sep 1991
MINIMAX (TM) HARDSHELL VENOUS RES W/INTE CARD FILT
K911789 · Medtronic Vascular · Aug 1991
MODEL 5866-46 SLEEVE KIT
K910568 · Medtronic Vascular · Apr 1991
BARD FILTERED CARDIOTOMY RESERVOIR
K902856 · C.R. Bard, Inc. · Sep 1990
MCR4000 & MCR4000F CARDIOTOMY RESERVOIR
K902355 · Medtronic Vascular · Aug 1990
CAP-35 AND CAP35 F
K874924 · Gish Biomedical, Inc. · Jan 1988