Cleared Traditional

K071494 - CAPIOX FX15 AND FX25 HOLLOW FIBER OXYGENATOR AND ARTERIAL FILTER

K071494 is an FDA 510(k) clearance for CAPIOX FX15 AND FX25 HOLLOW FIBER OXYGE..., manufactured by Terumo Corp.. The device is a Class 2 Cardiovascular device with product code DTZ cleared through the Traditional 510(k) pathway after a 47-day FDA review.

K071494 · Terumo Corp. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Jul 2007
Decision
47d
Days
Class 2
Risk

K071494 is an FDA 510(k) clearance for the CAPIOX FX15 AND FX25 HOLLOW FIBER OXYGENATOR AND ARTERIAL FILTER. Classified as Oxygenator, Cardiopulmonary Bypass (product code DTZ), Class II - Special Controls.

Submitted by Terumo Corp. (Elkton, US). The FDA issued a Cleared decision on July 16, 2007 after a review of 47 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Terumo Corp. devices

FDA 510(k) Submission Details - K071494

510(k) Number K071494 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 2007
Decision Date July 16, 2007
Days to Decision 47 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
78d faster than avg
Panel avg: 125d · This submission: 47d
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 233
Devices cleared under the same product code (DTZ) and FDA review panel - the closest regulatory comparables to K071494.
JOSTRA QUADROX D DIFFUSION MEMBRANE OXYGENATOR WITH BIOLINE COATING, MODEL BE-HMOD 2000, BEQ-HMOD 2030
K071774 · Maquet Cardiopulmonary, AG · Jan 2008
D101 KIDS INFANT HOLLOW FIBER MEMBRANE OXYGENATOR WITH INTEGRATED HARDSHELL CARDIOTOMY/VENOUS RESERVOIR
K072091 · Sorin Group Italia S.R.L. · Oct 2007
CAPIOX FX05 HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER
K071572 · Terumo Corp. · Jul 2007
CAPIOX RX OXYGENATOR WITH OR WITHOUT RESERVOIR
K062381 · Terumo Cardiovascular Systems Corp. · Aug 2006
JOSTRA QUADROX D SAFELINE DIFFUSION MEMBRANE OXYGENATOR, MODEL HMOD 2030
K061628 · Maquet Cardiopulmonary, AG · Aug 2006
D 100 L001 PH.I.S.I.O.: NEWBORN HOLLOW FIBER MEMBRANE OXYGENATOR WITH INTEGRATED HARDSHELL CARDIOTOMY/VENOUS RESERVOIR W
K061031 · Sorin Group Italia S.R.L. · Jun 2006