Cleared Special

K153140 - Terumo Capiox SX18 Oxygenator/ Hardshel...

K153140 is an FDA 510(k) clearance for Terumo Capiox SX18 Oxygenator/ Hardshel..., manufactured by Terumo Cardiovascular Systems Corp.. The device is a Class 2 Cardiovascular device with product code DTZ cleared through the Special 510(k) pathway after a 33-day FDA review.

K153140 · Terumo Cardiovascular Systems Corp. · Cardiovascular device
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Dec 2015
Decision
33d
Days
Class 2
Risk

K153140 is an FDA 510(k) clearance for the Terumo Capiox SX18 Oxygenator/ Hardshell Reservoir, Terumo Capiox SX18 Oxygen.... Classified as Oxygenator, Cardiopulmonary Bypass (product code DTZ), Class II - Special Controls.

Submitted by Terumo Cardiovascular Systems Corp. (Elkton, US). The FDA issued a Cleared decision on December 2, 2015 after a review of 33 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 Terumo Cardiovascular Systems Corp. devices

FDA 510(k) Submission Details - K153140

510(k) Number K153140 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 2015
Decision Date December 02, 2015
Days to Decision 33 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
92d faster than avg
Panel avg: 125d · This submission: 33d
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 202
Devices cleared under the same product code (DTZ) and FDA review panel - the closest regulatory comparables to K153140.
Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium Biosurface
K162896 · Medtronic, Inc. · Dec 2016
Affinity NT Oxygenator with Cortiva BioActive Surface
K162016 · Medtronic, Inc. · Sep 2016
Capiox RX Hollow Fiber Oxygenator with/without Hardshell Reservoir
K153213 · Terumo Cardiovascular Systems Corporation · Dec 2015
Terumo Capiox FX15 Advance Oxygenator with Integrated Arterial Filter and Reservoir, Terumo Capiox FX25 Advance Oxygenator with Integrated Arterial Filter and Reservoir
K151791 · Terumo Cardiovascular Systems Corporation · Nov 2015
LILLIPUP PMP, LILLIPUT PMP INTEGRATED
K151713 · Sorin Group Italia S.R.L. · Nov 2015
Terumo Capiox FX15 Advance Oxygenator with Integrated Arterial Filter and Hardshell Reservoir
K151389 · Terumo Cardiovascular Systems Corporation · Oct 2015