Cleared Traditional

K974155 - BMR 4500 FILTERED VENOUS RESERVOIR AND ...

K974155 is the FDA 510(k) clearance for BMR 4500 FILTERED VENOUS RESERVOIR AND ... by Baxter Healthcare Corp. It is a Class 2 Cardiovascular device (product code DTN) cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K974155 · Baxter Healthcare Corp · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1998
Decision
79d
Days
Class 2
Risk

K974155 is an FDA 510(k) clearance for the BMR 4500 FILTERED VENOUS RESERVOIR AND BMR -4500 GOLD FILTERED VENOUS RESERVO.... 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 22, 1998 after a review of 79 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 K974155 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 1997
Decision Date January 22, 1998
Days to Decision 79 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 125d · This submission: 79d
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 128
Devices cleared under the same product code (DTN) and FDA review panel - the closest regulatory comparables to K974155.
COBE CLOSED VENOUS RESERVOIR BAGS WITH SMARX T, MODELS VRB 1200 AND VRB 1800
K980786 · Cobe Cardiovascular, Inc. · Aug 1998
BARD QUANTUM SVR MODEL NUMBER H-6440VR
K981628 · C.R. Bard, Inc. · Aug 1998
CAPIOX SX HARDSHELL RESERVOIR
K980935 · Terumo Medical Corp. · May 1998
BIOCOR SOFTSHELL VENOUS RESERVOIR (BIOCOR SVR)
K972017 · Minntech Corp. · Sep 1997
COBE HVR 4000 FILTERED AND NONFILTERED HARDSHELL VENOUS RESERVOIR
K971669 · Cobe Cardiovascular, Inc. · Jul 1997
GISH CAP VRF45 CARDIOTOMY/VENOUS RESERVOIR
K964973 · Gish Biomedical, Inc. · Mar 1997