Cleared Traditional

K860673 - OXYGENATOR MODEL NOS. BENTLEY-10A & BEN...

K860673 is the FDA 510(k) clearance for OXYGENATOR MODEL NOS. BENTLEY-10A & BEN... by American Bentley. It is a Class 2 Cardiovascular device (product code DTZ) cleared through the Traditional 510(k) pathway after a 122-day FDA review.

K860673 · American Bentley · Cardiovascular device
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Jun 1986
Decision
122d
Days
Class 2
Risk

K860673 is an FDA 510(k) clearance for the OXYGENATOR MODEL NOS. BENTLEY-10A & BENTLEY-10B. 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 June 26, 1986 after a review of 122 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 K860673 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 1986
Decision Date June 26, 1986
Days to Decision 122 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
3d faster than avg
Panel avg: 125d · This submission: 122d
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 K860673.
SCIMED MEMBRANE OXYGENATOR SYSTEM - ECMO
K863476 · Scimed Life Systems, Inc. · Nov 1986
MODIFIED SARNS OXYGENATOR SYSTEM
K863515 · 3M Health Care, Sarns · Nov 1986
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