Cleared Traditional

K841476 - TUBULAR HOLLOW FIBER MEMBRANE

K841476 is the FDA 510(k) clearance for TUBULAR HOLLOW FIBER MEMBRANE by American Bentley. It is a Class 2 Cardiovascular device (product code DTZ) cleared through the Traditional 510(k) pathway after a 116-day FDA review.

K841476 · American Bentley · Cardiovascular device
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Aug 1984
Decision
116d
Days
Class 2
Risk

K841476 is an FDA 510(k) clearance for the TUBULAR HOLLOW FIBER MEMBRANE. Classified as Oxygenator, Cardiopulmonary Bypass (product code DTZ), Class II - Special Controls.

Submitted by American Bentley (Mchenry, US). The FDA issued a Cleared decision on August 3, 1984 after a review of 116 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4350 - 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. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all American Bentley devices

Submission Details

510(k) Number K841476 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 1984
Decision Date August 03, 1984
Days to Decision 116 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
9d faster than avg
Panel avg: 125d · This submission: 116d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DTZ Oxygenator, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4350
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 - DTZ Oxygenator, Cardiopulmonary Bypass

All 123
Devices cleared under the same product code (DTZ) and FDA review panel - the closest regulatory comparables to K841476.
VARIABLE PRIME COBE MEMBRANE LUNG
K842908 · Cobe Laboratories, Inc. · Feb 1985
SCIMED II MEMBRANE OXYGENATOR SYSTEM
K843956 · Scimed Life Systems, Inc. · Jan 1985
EXTRACORPOREAL MAXIMA HOLLOW FIBER OXYGENATOR
K843955 · Extracorporeal Medical Specialities, Inc. · Nov 1984
HOLLOW FIBER MEMBRANE OXYGENATOR-HF4000
K833078 · Cordis Corp. · Jan 1984
SHILEY M2000 MEMBRANE OXYGENATOR
K833253 · Shiley, Inc. · Dec 1983
BLOOD OXYGENATOR 5070
K831894 · Shiley, Inc. · Oct 1983