Cleared Traditional

K872167 - CARDIOTOMY/MEDIASTINAL AUTO. RESERVOIR ...

K872167 is the FDA 510(k) clearance for CARDIOTOMY/MEDIASTINAL AUTO. RESERVOIR ... by American Bentley. It is a Class 2 Cardiovascular device (product code DTP) cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K872167 · American Bentley · Cardiovascular device
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Sep 1987
Decision
85d
Days
Class 2
Risk

K872167 is an FDA 510(k) clearance for the CARDIOTOMY/MEDIASTINAL AUTO. RESERVOIR CATR-3500. Classified as Defoamer, Cardiopulmonary Bypass (product code DTP), Class II - Special Controls.

Submitted by American Bentley (Irvine, US). The FDA issued a Cleared decision on September 1, 1987 after a review of 85 days - a notably fast clearance 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: 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 American Bentley devices

Submission Details

510(k) Number K872167 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 1987
Decision Date September 01, 1987
Days to Decision 85 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 125d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 23
Devices cleared under the same product code (DTP) and FDA review panel - the closest regulatory comparables to K872167.
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
THORASTAT ATR-XXXX
K870792 · Gish Biomedical, Inc. · Apr 1987
SARNS FILTERED CARDIOTOMY RESERVOIR
K860702 · 3M Health Care, Sarns · May 1986
MODIFIED MODEL SC4000(F) CARDIOTOMY RESERVOIR
K855049 · Scimed Life Systems, Inc. · Feb 1986