Cleared Traditional

K151389 - Terumo Capiox FX15 Advance Oxygenator w...

K151389 is the FDA 510(k) clearance for Terumo Capiox FX15 Advance Oxygenator w... by Terumo Cardiovascular Systems Corporation. It is a Class 2 Cardiovascular device (product code DTZ) cleared through the Traditional 510(k) pathway after a 147-day FDA review.

K151389 · Terumo Cardiovascular Systems Corporation · Cardiovascular device
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Oct 2015
Decision
147d
Days
Class 2
Risk

K151389 is an FDA 510(k) clearance for the Terumo Capiox FX15 Advance Oxygenator with Integrated Arterial Filter and Har.... Classified as Oxygenator, Cardiopulmonary Bypass (product code DTZ), Class II - Special Controls.

Submitted by Terumo Cardiovascular Systems Corporation (Elkton, US). The FDA issued a Cleared decision on October 20, 2015 after a review of 147 days - within the typical 510(k) review window.

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 Terumo Cardiovascular Systems Corporation devices

Submission Details

510(k) Number K151389 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 26, 2015
Decision Date October 20, 2015
Days to Decision 147 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
22d slower than avg
Panel avg: 125d · This submission: 147d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 192
Devices cleared under the same product code (DTZ) and FDA review panel - the closest regulatory comparables to K151389.
Affinity NT Oxygenator with Cortiva BioActive Surface
K162016 · Medtronic, Inc. · Sep 2016
Terumo Capiox SX18 Oxygenator/ Hardshell Reservoir, Terumo Capiox SX18 Oxygenator/ Hardshell Reservoir with Xcoating, Terumo Capiox SX25 Oxygenator/Hardshell Reservoir, Terumo Capiox SX25 Oxygenator/Hardshell Reservoir with Xcoating
K153140 · Terumo Cardiovascular Systems Corp. · Dec 2015
LILLIPUP PMP, LILLIPUT PMP INTEGRATED
K151713 · Sorin Group Italia S.R.L. · Nov 2015
EOS PMP, EOS PMP Integrated
K150489 · Sorin Group Italia S.R.L. · Jun 2015
QUADROX-i Adult/Small Adult Oxygenators
K150267 · Maquet Cardiopulmonary, AG · May 2015
Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium Biosurface, Affinity NT Oxygenator with Carmeda Biosurface
K143073 · Medtronic, Inc. · Mar 2015