Cleared Traditional

K963518 - COBE OPTIMA XP HOLLOW FIBER MEMBRANE OX...

K963518 is an FDA 510(k) clearance for COBE OPTIMA XP HOLLOW FIBER MEMBRANE OX..., manufactured by Cobe Cardiovascular, Inc.. The device is a Class 2 Cardiovascular device with product code DTZ cleared through the Traditional 510(k) pathway after a 461-day FDA review.

K963518 · Cobe Cardiovascular, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1997
Decision
461d
Days
Class 2
Risk

K963518 is an FDA 510(k) clearance for the COBE OPTIMA XP HOLLOW FIBER MEMBRANE OXYGENATOR. Classified as Oxygenator, Cardiopulmonary Bypass (product code DTZ), Class II - Special Controls.

Submitted by Cobe Cardiovascular, Inc. (Arvada, US). The FDA issued a Cleared decision on December 8, 1997 after a review of 461 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

View all Cobe Cardiovascular, Inc. devices

FDA 510(k) Submission Details - K963518

510(k) Number K963518 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 1996
Decision Date December 08, 1997
Days to Decision 461 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
336d slower than avg
Panel avg: 125d · This submission: 461d
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 202
Devices cleared under the same product code (DTZ) and FDA review panel - the closest regulatory comparables to K963518.
MODIFICATION OF MAXIMA FORTE' HOLLOW FIBER OXYGENATOR WITH BALANCE BIOCOMPATIBLE SURFACE WITH PLASMA RESISTENT FIBER (M0
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K974085 · Cobe Cardiovascular, Inc. · Jan 1998
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K964043 · Cobe Cardiovascular, Inc. · Sep 1997
CAPIOX 308 HOLLOW FIBER OXYGENATOR W/INTEGRATED HEAT EXCHANGE
K961734 · Terumo Medical Corp. · Jul 1997
CAPIOX E HOLLOW FIBER OXYGENATOR WITH INTEGRATED HEAT EXCHANGER/ARTERIAL RESERVOIR
K970463 · Terumo Medical Corp. · May 1997