Cleared Traditional

K834373 - CARDIOTOMY RESERVORS BCR-3000/3500-Q-120

K834373 is the FDA 510(k) clearance for CARDIOTOMY RESERVORS BCR-3000/3500-Q-120 by American Bentley. It is a Class 2 Cardiovascular device (product code DTN) cleared through the Traditional 510(k) pathway after a 54-day FDA review.

K834373 · American Bentley · Cardiovascular device
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Feb 1984
Decision
54d
Days
Class 2
Risk

K834373 is an FDA 510(k) clearance for the CARDIOTOMY RESERVORS BCR-3000/3500-Q-120. Classified as Reservoir, Blood, Cardiopulmonary Bypass (product code DTN), Class II - Special Controls.

Submitted by American Bentley (Walker, US). The FDA issued a Cleared decision on February 4, 1984 after a review of 54 days - a notably fast clearance 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: 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 K834373 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 1983
Decision Date February 04, 1984
Days to Decision 54 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
71d faster than avg
Panel avg: 125d · This submission: 54d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 78
Devices cleared under the same product code (DTN) and FDA review panel - the closest regulatory comparables to K834373.
SHILEY CARDIOTOMY RESERVOIR W/FILTER
K842711 · Shiley, Inc. · Aug 1984
WILLIAM HARVEY H-4720 NON-FILTERED CAR
K841175 · C.R. Bard, Inc. · Apr 1984
WILLIAM HARVEY H-4700 FILTER/CARDIO
K841079 · C.R. Bard, Inc. · Apr 1984
CARDIOTOMY RESERVOIR-FILTER 050-108-050
K832671 · Cobe Laboratories, Inc. · Dec 1983
WILLIAM HARVEY H-71-5-F CARDIOTOMY
K833479 · C.R. Bard, Inc. · Dec 1983
VENOUS RESERVOIR
K832924 · Shiley, Inc. · Oct 1983