Cleared Traditional

K223168 - Tubing and Accessories Sets for Extraco...

K223168 is an FDA 510(k) clearance for Tubing and Accessories Sets for Extraco..., manufactured by Medtronic, Inc.. The device is a Class 2 Cardiovascular device with product code QWF cleared through the Traditional 510(k) pathway after a 190-day FDA review.

K223168 · Medtronic, Inc. · Cardiovascular device
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Apr 2023
Decision
190d
Days
Class 2
Risk

K223168 is an FDA 510(k) clearance for the Tubing and Accessories Sets for Extracorporeal Membrane Oxygenation (ECMO) wi.... Classified as Tubing, Long Term Support Greater Than 6 Hours (product code QWF), Class II - Special Controls.

Submitted by Medtronic, Inc. (Mounds View, US). The FDA issued a Cleared decision on April 19, 2023 after a review of 190 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4100 - 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 Medtronic, Inc. devices

FDA 510(k) Submission Details - K223168

510(k) Number K223168 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 2022
Decision Date April 19, 2023
Days to Decision 190 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
65d slower than avg
Panel avg: 125d · This submission: 190d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

QWF Device Classification - Class 2, Special Controls

Product Code QWF Tubing, Long Term Support Greater Than 6 Hours
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4100
Definition The Tubing And Accessories Are Intended To Connect Perfusion Devices And Circulate Blood As Part Of Extracorporeal Membrane Oxygenation Lasting Longer Than 6 Hours.
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.