510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K223168Substantially Equivalent

Tubing and Accessories Sets for Extracorporeal Membrane Oxygenation (ECMO) with Balance™ Biosurface

Medtronic, Inc., Mounds View MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K223168 is the FDA 510(k) clearance record for Tubing and Accessories Sets for Extracorporeal Membrane Oxygenation (ECMO) with Balance™ Biosurface, a class II device, cleared for Medtronic, Inc. on under FDA product code QWF (Tubing, Long Term Support Greater Than 6 Hours). FDA's definition for product code QWF reads: "The tubing and accessories are intended to connect perfusion devices and circulate blood as part of extracorporeal membrane oxygenation lasting longer than 6 hours". FDA records list 1,525 510(k) clearances for Medtronic, Inc., from to . As of , FDA records show no recalls naming K223168.

Clearance record

Decision date
Received
(190 days to decision)
Product code
QWF Tubing, Long Term Support Greater Than 6 Hours
Regulation
21 CFR 870.4100
Device class
Class II
Review panel
Cardiovascular
Applicant
Medtronic, Inc. 8200 Coral Sea St. N.E, Mounds View MN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QWF

Trailing 12 months

FDA records hold no clearances under product code QWF in the trailing twelve months.

FDA records show no clearances under product code QWF in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QWF, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260