Cleared Traditional

K233702 - SMARxT Tubing and Connectors

K233702 is an FDA 510(k) clearance for SMARxT Tubing and Connectors, manufactured by LivaNova USA, Inc.. The device is a Class 2 Cardiovascular device with product code DWE cleared through the Traditional 510(k) pathway after a 265-day FDA review.

K233702 · LivaNova USA, Inc. · Cardiovascular device
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Aug 2024
Decision
265d
Days
Class 2
Risk

K233702 is an FDA 510(k) clearance for the SMARxT Tubing and Connectors. Classified as Tubing, Pump, Cardiopulmonary Bypass (product code DWE), Class II - Special Controls.

Submitted by LivaNova USA, Inc. (Arvada, US). The FDA issued a Cleared decision on August 8, 2024 after a review of 265 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4390 - 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 LivaNova USA, Inc. devices

FDA 510(k) Submission Details - K233702

510(k) Number K233702 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 2023
Decision Date August 08, 2024
Days to Decision 265 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
140d slower than avg
Panel avg: 125d · This submission: 265d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DWE Device Classification - Class 2, Special Controls

Product Code DWE Tubing, Pump, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4390
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 - DWE Tubing, Pump, Cardiopulmonary Bypass

All 15
Devices cleared under the same product code (DWE) and FDA review panel - the closest regulatory comparables to K233702.
Terumo Pump Tubing
K150542 · Terumo Cardiovascular Systems Corporation · May 2015
AngioVac Circuit
K142607 · Angiodynamics · Dec 2014
HLM TUBING SET WITH BIOLINE COATING
K080592 · Maquet Cardiopulmonary, AG · Sep 2008
JOSTRA HLM TUBING SET
K053025 · Maquet Cardiopulmonary, AG · Nov 2005
PUMP TUBING WITH X-COATING
K022857 · Terumo Cardiovascular Systems Corporation · Sep 2002
PUMP TUBING
K013578 · Terumo Cardiovascular Systems Corp. · Jan 2002