Cleared Traditional

K153295 - TandemLung Oxygenator

K153295 is an FDA 510(k) clearance for TandemLung Oxygenator, manufactured by Cardiacassist, Inc.. The device is a Class 2 Cardiovascular device with product code DTZ cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K153295 · Cardiacassist, Inc. · Cardiovascular device
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Feb 2016
Decision
105d
Days
Class 2
Risk

K153295 is an FDA 510(k) clearance for the TandemLung Oxygenator. Classified as Oxygenator, Cardiopulmonary Bypass (product code DTZ), Class II - Special Controls.

Submitted by Cardiacassist, Inc. (Pittsburgh, US). The FDA issued a Cleared decision on February 26, 2016 after a review of 105 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 Cardiacassist, Inc. devices

FDA 510(k) Submission Details - K153295

510(k) Number K153295 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 2015
Decision Date February 26, 2016
Days to Decision 105 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
20d faster than avg
Panel avg: 125d · This submission: 105d
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 235
Devices cleared under the same product code (DTZ) and FDA review panel - the closest regulatory comparables to K153295.
Affinity Fusion Oxygenator with Balance Biosurface, Affinity Fusion Oxygenator with Cardiotomy/Venous Reservoir and Balance Biosurface, Affinity Fusion Oxygenator with Cortiva Biosurface, Affinity Fusion Oxygenator with Cortiva BioActive Surface & Cardiotomy/Venous Reservoir
K172626 · Medtronic, Inc. · Oct 2017
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 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
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