Cleared Traditional

VENOUS RESERVOIR BAG MODEL NO. BMR-800 W/HEPARIN (K896414) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K896414 · Baxter Healthcare Corp · Cardiovascular device
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Jan 1990
Decision
84d
Days
Class 2
Risk

K896414 is an FDA 510(k) clearance for the VENOUS RESERVOIR BAG MODEL NO. BMR-800 W/HEPARIN. Classified as Reservoir, Blood, Cardiopulmonary Bypass (product code DTN), Class II - Special Controls.

Submitted by Baxter Healthcare Corp (Irvine, US). The FDA issued a Cleared decision on January 31, 1990 after a review of 84 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 Baxter Healthcare Corp devices

Submission Details

510(k) Number K896414 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 1989
Decision Date January 31, 1990
Days to Decision 84 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
41d faster than avg
Panel avg: 125d · This submission: 84d
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 46
Devices cleared under the same product code (DTN) and FDA review panel - the closest regulatory comparables to K896414.
SOFTSHELL VENOUS RESERVOIR
K904040 · C.R. Bard, Inc. · Dec 1990
UNIVOX-IC
K895356 · Baxter Healthcare Corp · Mar 1990
DIDECO-SHILEY AUTOTRANSFUSION CARDIOTOMY RESERVOIR
K893711 · Shiley, Inc. · Feb 1990
DIDECO-SHILEY AUTOTRANSFUSION CARDIOTOMY RESERVOIR
K884872 · Shiley, Inc. · Jan 1989
MAXIMA* COLLAPSIBLE VENOUS RESERVOIR BAG & HOLDER
K873423 · Johnson & Johnson Professionals, Inc. · Nov 1987
EXPANDED USE OF HARDSHELL VENOUS RESERV. W/FILTER
K872719 · Shiley, Inc. · Sep 1987