Cleared Traditional

K971421 - BARD ISOFLOW BLOOD PUMP

K971421 is an FDA 510(k) clearance for BARD ISOFLOW BLOOD PUMP, manufactured by C.R. Bard, Inc.. The device is a Class 2 Cardiovascular device with product code DWA cleared through the Traditional 510(k) pathway after a 393-day FDA review.

K971421 · C.R. Bard, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 1998
Decision
393d
Days
Class 2
Risk

K971421 is an FDA 510(k) clearance for the BARD ISOFLOW BLOOD PUMP. Classified as Control, Pump Speed, Cardiopulmonary Bypass (product code DWA), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Haverhill, US). The FDA issued a Cleared decision on May 14, 1998 after a review of 393 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4380 - 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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K971421

510(k) Number K971421 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 1997
Decision Date May 14, 1998
Days to Decision 393 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
268d slower than avg
Panel avg: 125d · This submission: 393d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DWA Device Classification - Class 2, Special Controls

Product Code DWA Control, Pump Speed, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4380
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 - DWA Control, Pump Speed, Cardiopulmonary Bypass

All 36
Devices cleared under the same product code (DWA) and FDA review panel - the closest regulatory comparables to K971421.
STOCKERT SCP RHYTHM
K042374 · Stockert Instrumente GmbH · Sep 2004
STOCKERT CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP
K032213 · Stockert Instrumente GmbH · Aug 2003
CENTRIFUGAL PUMP
K011838 · Stockert Instrumente GmbH · Feb 2002
3M SARNS FLOW SENSOR, CENTRIFUGAL CONTROL MODULE 115, 220 V, 900 PERFUSION SYSTEM
K950739 · 3M Health Care, Sarns · Nov 1995
MEDTRONIC BIO-MEDICUS BIO-CONSOLE MODEL 550M PUMP SPEED CONTROLLER
K936091 · Medtronic Bio-Medicus, Inc. · Dec 1994
BIO-MEDICUS BIO-CONSOLE MODELS 540, 540A,B,C,D,E, & 550
K941921 · Medtronic Bio-Medicus, Inc. · Jul 1994
K971421 · BARD ISOFLOW BLOOD PUMP
Download PDF FDA Summary C.R. Bard, Inc.