Cleared Traditional

K854045 - MEMBRANE OXYGENATING SYS ADULT BMOS-7 &...

K854045 is the FDA 510(k) clearance for MEMBRANE OXYGENATING SYS ADULT BMOS-7 &... by American Bentley. It is a Class 2 Cardiovascular device (product code DTZ) cleared through the Traditional 510(k) pathway after a 75-day FDA review.

K854045 · American Bentley · Cardiovascular device
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Dec 1985
Decision
75d
Days
Class 2
Risk

K854045 is an FDA 510(k) clearance for the MEMBRANE OXYGENATING SYS ADULT BMOS-7 & BMOS-3 PED. 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 December 16, 1985 after a review of 75 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 K854045 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 1985
Decision Date December 16, 1985
Days to Decision 75 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 125d · This submission: 75d
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 K854045.
SCIMED II-SM25 MEMBRANE OXYGENATOR SYSTEM
K862918 · Scimed Life Systems, Inc. · Sep 1986
CAPIOX III CARDIOPULMONARY BYPASS OXYGENATOR
K861177 · Terumo Medical Corp. · May 1986
SARNS OXYGENATOR SYSTEM
K860539 · 3M Health Care, Sarns · Apr 1986
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
VARIABLE PRIME COBE MEMBRANE LUNG
K842908 · Cobe Laboratories, Inc. · Feb 1985