Cleared Traditional

K926467 - COBE CMS-FS MEMBRANE OXYGENATOR

K926467 is an FDA 510(k) clearance for COBE CMS-FS MEMBRANE OXYGENATOR, 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 316-day FDA review.

K926467 · Cobe Cardiovascular, Inc. · Cardiovascular device
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Nov 1993
Decision
316d
Days
Class 2
Risk

K926467 is an FDA 510(k) clearance for the COBE CMS-FS 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 November 9, 1993 after a review of 316 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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Cardiovascular, Inc. devices

FDA 510(k) Submission Details - K926467

510(k) Number K926467 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 28, 1992
Decision Date November 09, 1993
Days to Decision 316 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
191d slower than avg
Panel avg: 125d · This submission: 316d
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 K926467.
UNIVIX GOLD MEMBRANE OXYGENATION MODULE WITH DUROFLO II HEPARIN TREATMENT
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K933586 · Medtronic Vascular · Feb 1994
CAPIOX SX HOLLOW FIBER OXYGENATOR
K922799 · Terumo Medical Corp. · Sep 1993
INTERSEPT FILTERED CARDIOTOMY RESERVOIR
K926226 · Medtronic Vascular · Jun 1993
SARNS TURBO MEMBRANE OXYGENA. W/INT. RESERVOIR
K925075 · 3M Health Care, Sarns · Jun 1993