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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 / K260044

510(k) cleared

Ventricular Catheters, Thomale Catheter

Aesculap, Inc. · Oct 2, 2026 · K260044

FDA cleared the Ventricular Catheters, Thomale Catheter from Aesculap, Inc. on Oct 2, 2026 under K260044, a traditional 510(k). The device falls under product code JXG, Shunt, Central Nervous System And Components, regulated at 21 CFR 882.5550 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on Jan 7, 2026. The decision came 268 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 Aesculap, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260044?

K260044 is the FDA 510(k) for Ventricular Catheters, Thomale Catheter, submitted by Aesculap, Inc.. FDA's decision date was Oct 2, 2026, under product code JXG (Shunt, Central Nervous System And Components).

Who makes the Ventricular Catheters, Thomale Catheter?

Aesculap, Inc., based in Center Valley, PA, is the applicant of record for K260044.

How long did the K260044 review take?

FDA received the submission on Jan 7, 2026 and issued its decision on Oct 2, 2026, 268 days later.

← All decisions in October 2026