Cleared Traditional

K833518 - BLOOD OXYGENATOR HEAT EXHANGER COATING

K833518 is the FDA 510(k) clearance for BLOOD OXYGENATOR HEAT EXHANGER COATING by American Bentley. It is a Class 2 Cardiovascular device (product code DTZ) cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K833518 · American Bentley · Cardiovascular device
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Dec 1983
Decision
79d
Days
Class 2
Risk

K833518 is an FDA 510(k) clearance for the BLOOD OXYGENATOR HEAT EXHANGER COATING. Classified as Oxygenator, Cardiopulmonary Bypass (product code DTZ), Class II - Special Controls.

Submitted by American Bentley (Walker, US). The FDA issued a Cleared decision on December 29, 1983 after a review of 79 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4350 - 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: 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 American Bentley devices

Submission Details

510(k) Number K833518 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 1983
Decision Date December 29, 1983
Days to Decision 79 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
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 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 K833518.
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
BLOOD OXYGENATOR 50 70/S
K831895 · Shiley, Inc. · Oct 1983