Cleared Traditional

K851376 - VENOUS RESERVOIR BAG BMR-1600

K851376 is an FDA 510(k) clearance for VENOUS RESERVOIR BAG BMR-1600, manufactured by American Bentley. The device is a Class 2 Cardiovascular device with product code DTN cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K851376 · American Bentley · Cardiovascular device
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Jun 1985
Decision
78d
Days
Class 2
Risk

K851376 is an FDA 510(k) clearance for the VENOUS RESERVOIR BAG BMR-1600. Classified as Reservoir, Blood, Cardiopulmonary Bypass (product code DTN), Class II - Special Controls.

Submitted by American Bentley (Irvine, US). The FDA issued a Cleared decision on June 25, 1985 after a review of 78 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

FDA 510(k) Submission Details - K851376

510(k) Number K851376 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 1985
Decision Date June 25, 1985
Days to Decision 78 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
47d faster than avg
Panel avg: 125d · This submission: 78d
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 143
Devices cleared under the same product code (DTN) and FDA review panel - the closest regulatory comparables to K851376.
MODIFIED CARDIOTOMY RESERVOIR 5M1470
K862357 · 3M Health Care, Sarns · Aug 1986
SHILEY VENOUS RESERVOIR
K854841 · Shiley, Inc. · Feb 1986
CARDIOTOMY/MEDIASTINAL AUTOTRANSFUSION RESERVOIR
K852382 · American Bentley · Sep 1985
VENUOS RESERVOIR BAG BMR-1900
K851401 · American Bentley · Jun 1985
ACR 2500 CARDIOTOMY RESERVOIR FILTER
K842391 · Electromedics, Inc. · May 1985
CARDIOTOMY RESERVOIR BRS-XXX SERIES &
K843888 · Gish Biomedical, Inc. · Feb 1985