Cleared Traditional

DURAFLO II HEPARIN TREATED SUCTION WANDS VAR. MOD. (K905311) - FDA 510(k) Clearance

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

K905311 · Baxter Bentley Laboratories, Inc. · Cardiovascular device
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Jan 1991
Decision
48d
Days
Class 2
Risk

K905311 is an FDA 510(k) clearance for the DURAFLO II HEPARIN TREATED SUCTION WANDS VAR. MOD.. Classified as Suction Control, Intracardiac, Cardiopulmonary Bypass (product code DWD), Class II - Special Controls.

Submitted by Baxter Bentley Laboratories, Inc. (Irvine, US). The FDA issued a Cleared decision on January 15, 1991 after a review of 48 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4430 - 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 Bentley Laboratories, Inc. devices

Submission Details

510(k) Number K905311 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 28, 1990
Decision Date January 15, 1991
Days to Decision 48 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 125d · This submission: 48d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DWD Suction Control, Intracardiac, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4430
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 - DWD Suction Control, Intracardiac, Cardiopulmonary Bypass

All 14
Devices cleared under the same product code (DWD) and FDA review panel - the closest regulatory comparables to K905311.
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B-D ULTRA-VUE PROCEDURE NEEDLE W/ CHIBA TYPE POINT
K915481 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jan 1992
B-D ULTRA-VUE PROCEDURE NEEDLE W/ WESTCOTT TYPE PT
K915482 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jan 1992
IL VIDEO 22,21 & II ATOMIC SPECTROPHOTO-
K830149 · Instrumentation Laboratory CO · Feb 1983