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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 / K262068

510(k) cleared

Khelix Magnetic Sensor Electrophysiology Catheter (SS1---MAG)

CathRx, Ltd. · Oct 9, 2026 · K262068

FDA cleared the Khelix Magnetic Sensor Electrophysiology Catheter (SS1-*-*-MAG) from CathRx, Ltd. on Oct 9, 2026 under K262068, a traditional 510(k). The device falls under product code DRF, Catheter, Electrode Recording, Or Probe, Electrode Recording, regulated at 21 CFR 870.1220 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Jun 22, 2026. The decision came 109 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for CathRx, Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K262068?

K262068 is the FDA 510(k) for Khelix Magnetic Sensor Electrophysiology Catheter (SS1-*-*-MAG), submitted by CathRx, Ltd.. FDA's decision date was Oct 9, 2026, under product code DRF (Catheter, Electrode Recording, Or Probe, Electrode Recording).

Who makes the Khelix Magnetic Sensor Electrophysiology Catheter (SS1---MAG)?

CathRx, Ltd., based in Rydalmere, is the applicant of record for K262068.

How long did the K262068 review take?

FDA received the submission on Jun 22, 2026 and issued its decision on Oct 9, 2026, 109 days later.

← All decisions in October 2026