Cleared Special

K014080 - APEX ADULT HOLLOWE FIBER OXYGENATOR

K014080 is an FDA 510(k) clearance for APEX ADULT HOLLOWE FIBER OXYGENATOR, manufactured by Dideco S.P.A.. The device is a Class 2 Cardiovascular device with product code DTZ cleared through the Special 510(k) pathway after a 28-day FDA review.

K014080 · Dideco S.P.A. · Cardiovascular device
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Jan 2002
Decision
28d
Days
Class 2
Risk

K014080 is an FDA 510(k) clearance for the APEX ADULT HOLLOWE FIBER OXYGENATOR. Classified as Oxygenator, Cardiopulmonary Bypass (product code DTZ), Class II - Special Controls.

Submitted by Dideco S.P.A. (Waltham, US). The FDA issued a Cleared decision on January 8, 2002 after a review of 28 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Dideco S.P.A. devices

FDA 510(k) Submission Details - K014080

510(k) Number K014080 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 2001
Decision Date January 08, 2002
Days to Decision 28 days
Submission Type Special
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
97d faster than avg
Panel avg: 125d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

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 212
Devices cleared under the same product code (DTZ) and FDA review panel - the closest regulatory comparables to K014080.
INTEGRATED UNIT: SYNTHESIS: ADULT MEMBRANE OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDHSHELL VENOUS/CARDIOTOMY
K022450 · Dideco S.P.A. · Oct 2002
APEX PH.I.S.I.O. ADULT HOLLOW FIBER MEMBRANE OXYGENATOR
K020997 · Dideco S.P.A. · Apr 2002
D 903 AVANT 2 PH.I.S.I.O. ADULT HOLLOW FIBER OXYGENATOR
K020351 · Dideco S.P.A. · Feb 2002
D902 PH.I.S.I.O OXYGENATOR
K013915 · Dideco S.P.A. · Dec 2001
CAPIOX SX10 HOLLOW FIBER OXYGENATOR WITH/WITHOUT HARDSHELL RESERVOIR WITH X-COATING
K010443 · Terumo Cardiovascular Systems Corp. · Dec 2001
COBE SMARXT OPTIMIN SURFACE MODIFIED HOLLOW FIBER MEMBRANE OXYGENATOR
K013480 · Cobe Cardiovascular, Inc. · Nov 2001