Cleared Traditional

K851035 - AMERICAN BENTLEY OXYGENATOR MAX-2

K851035 is an FDA 510(k) clearance for AMERICAN BENTLEY OXYGENATOR MAX-2, manufactured by American Bentley. The device is a Class 2 Cardiovascular device with product code DTZ cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K851035 · American Bentley · Cardiovascular device
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May 1985
Decision
64d
Days
Class 2
Risk

K851035 is an FDA 510(k) clearance for the AMERICAN BENTLEY OXYGENATOR MAX-2. Classified as Oxygenator, Cardiopulmonary Bypass (product code DTZ), Class II - Special Controls.

Submitted by American Bentley (Irvine, US). The FDA issued a Cleared decision on May 16, 1985 after a review of 64 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

FDA 510(k) Submission Details - K851035

510(k) Number K851035 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 1985
Decision Date May 16, 1985
Days to Decision 64 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 125d · This submission: 64d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DTZ Device Classification - Class 2, Special Controls

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 220
Devices cleared under the same product code (DTZ) and FDA review panel - the closest regulatory comparables to K851035.
MEMBRANE OXYGENATING SYS ADULT BMOS-7 & BMOS-3 PED
K854045 · American Bentley · Dec 1985
J & J CARDIOVASCULAR MAXIMA HOLLOW FIBER OXYGENATO
K853251 · Johnson & Johnson Professionals, Inc. · Oct 1985
WILLIAM HARVEY HYBID OXYGENATOR H-1700
K853080 · C.R. Bard, Inc. · Oct 1985
BLOOD OXYGENATOR MODEL NO. MAX-5
K850630 · American Bentley · Mar 1985
AMER. BENTLEY OXYGENATOR MAX-10 W/SMOOTH HEAT EXCH
K844901 · American Bentley · Mar 1985
VARIABLE PRIME COBE MEMBRANE LUNG
K842908 · Cobe Laboratories, Inc. · Feb 1985