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Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets

The Tracker / July 2026 / K261335

510(k) cleared

VitalFlow Set with Balance Biosurface

Medtronic, Inc. · Jul 31, 2026 · K261335

FDA cleared the VitalFlow Set with Balance Biosurface from Medtronic, Inc. on Jul 31, 2026 under K261335, a traditional 510(k). The device falls under product code QJZ, Extracorporeal System For Long-Term Respiratory / Cardiopulmonary Failure, regulated at 21 CFR 870.4100 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Apr 23, 2026. The decision came 99 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Medtronic, Inc. has 8 other decisions in the tracker over the last 12 months: K262913 (Protégé EverFlex Self-expanding Peripheral Stent System), K262735 (LINQ II Insertable Cardiac Monitor (ICM) (LNQ22)), K262005 (Affera Integrated Mapping System), K261866 (Concerto Versa Detachable Coil).

Questions & Answers

What did FDA clear under K261335?

K261335 is the FDA 510(k) for VitalFlow Set with Balance Biosurface, submitted by Medtronic, Inc.. FDA's decision date was Jul 31, 2026, under product code QJZ (Extracorporeal System For Long-Term Respiratory / Cardiopulmonary Failure).

Who makes the VitalFlow Set with Balance Biosurface?

Medtronic, Inc., based in Minneapolis, MN, is the applicant of record for K261335.

How long did the K261335 review take?

FDA received the submission on Apr 23, 2026 and issued its decision on Jul 31, 2026, 99 days later.

← All decisions in July 2026