Cleared Traditional

K851401 - VENUOS RESERVOIR BAG BMR-1900

K851401 is an FDA 510(k) clearance for VENUOS RESERVOIR BAG BMR-1900, 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 77-day FDA review.

K851401 · American Bentley · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1985
Decision
77d
Days
Class 2
Risk

K851401 is an FDA 510(k) clearance for the VENUOS RESERVOIR BAG BMR-1900. 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 77 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 - K851401

510(k) Number K851401 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 1985
Decision Date June 25, 1985
Days to Decision 77 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
48d faster than avg
Panel avg: 125d · This submission: 77d
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 K851401.
SHILEY VENOUS RESERVOIR
K854841 · Shiley, Inc. · Feb 1986
CARDIOTOMY/MEDIASTINAL AUTOTRANSFUSION RESERVOIR
K852382 · American Bentley · Sep 1985
VENOUS RESERVOIR BAG BMR-1600
K851376 · 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
SHILEY HARDSHELL VENOUS RESERVOIR W/INT
K843232 · Shiley, Inc. · Jan 1985