Cleared Traditional

K153295 - TandemLung Oxygenator (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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
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.

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 253
Devices cleared under the same product code (DTZ) and FDA review panel - the closest regulatory comparables to K153295.
Lifemotion Disposable Membrane Oxygenator
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Quantum Perfusion Blood Oxygenator VT75-E1, Quantum Perfusion Blood Oxygenator VT75-E2
K231982 · Qura S.R.L · Sep 2024
Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface (BB811)
K240666 · Medtronic Perfusion Systems · Jul 2024