Cleared Traditional

K842908 - VARIABLE PRIME COBE MEMBRANE LUNG

K842908 is an FDA 510(k) clearance for VARIABLE PRIME COBE MEMBRANE LUNG, manufactured by Cobe Laboratories, Inc.. The device is a Class 2 Cardiovascular device with product code DTZ cleared through the Traditional 510(k) pathway after a 192-day FDA review.

K842908 · Cobe Laboratories, Inc. · Cardiovascular device
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Feb 1985
Decision
192d
Days
Class 2
Risk

K842908 is an FDA 510(k) clearance for the VARIABLE PRIME COBE MEMBRANE LUNG. Classified as Oxygenator, Cardiopulmonary Bypass (product code DTZ), Class II - Special Controls.

Submitted by Cobe Laboratories, Inc. (Lakewood, US). The FDA issued a Cleared decision on February 1, 1985 after a review of 192 days - an extended review 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: 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 Cobe Laboratories, Inc. devices

FDA 510(k) Submission Details - K842908

510(k) Number K842908 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 1984
Decision Date February 01, 1985
Days to Decision 192 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
67d slower than avg
Panel avg: 125d · This submission: 192d
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 K842908.
AMERICAN BENTLEY OXYGENATOR MAX-2
K851035 · American Bentley · May 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
SCIMED II MEMBRANE OXYGENATOR SYSTEM
K843956 · Scimed Life Systems, Inc. · Jan 1985
EXTRACORPOREAL MAXIMA HOLLOW FIBER OXYGENATOR
K843955 · Extracorporeal Medical Specialities, Inc. · Nov 1984
TUBULAR HOLLOW FIBER MEMBRANE
K841476 · American Bentley · Aug 1984