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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 / October 2026 / K263092

510(k) cleared

Dual Stage Venous Cannulae

Sorin Group Italia S.R.L. · Oct 1, 2026 · K263092

FDA cleared the Dual Stage Venous Cannulae from Sorin Group Italia S.R.L. on Oct 1, 2026 under K263092, a special 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 Sep 3, 2026. The decision came 28 days later, inside the 90 FDA-day goal for a 510(k).

Sorin Group Italia S.R.L. has 4 other decisions in the tracker over the last 12 months: K262052 (Tri 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 K263092?

K263092 is the FDA 510(k) for Dual Stage Venous Cannulae, submitted by Sorin Group Italia S.R.L.. FDA's decision date was Oct 1, 2026, under product code DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass).

Who makes the Dual Stage Venous Cannulae?

Sorin Group Italia S.R.L., based in Mirandola, is the applicant of record for K263092.

How long did the K263092 review take?

FDA received the submission on Sep 3, 2026 and issued its decision on Oct 1, 2026, 28 days later.

← All decisions in October 2026

Sources