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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 / September 2026 / K262052

510(k) cleared

Tri Stage Venous Cannulae

Sorin Group Italia S.R.L. · Sep 28, 2026 · K262052

FDA cleared the Tri Stage Venous Cannulae from Sorin Group Italia S.R.L. on Sep 28, 2026 under K262052, a traditional 510(k). The device falls under product code DWF, Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass, regulated at 21 CFR 870.4210 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Jun 18, 2026. The decision came 102 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Sorin Group Italia S.R.L. has 4 other decisions in the tracker over the last 12 months: K263092 (Dual Stage Venous Cannulae), K253671 (Dual Stage Venous Cannulae), K251783 (Inspire HCR and HCR DUAL cardiotomy reservoirs), K253616 (ProtekDilate Vascular Access Kit).

Questions & Answers

What did FDA clear under K262052?

K262052 is the FDA 510(k) for Tri Stage Venous Cannulae, submitted by Sorin Group Italia S.R.L.. FDA's decision date was Sep 28, 2026, under product code DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass).

Who makes the Tri Stage Venous Cannulae?

Sorin Group Italia S.R.L., based in Mirandola, is the applicant of record for K262052.

How long did the K262052 review take?

FDA received the submission on Jun 18, 2026 and issued its decision on Sep 28, 2026, 102 days later.

← All decisions in September 2026

Sources