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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 / K261521

510(k) cleared

Sleep Analysis Module

Neurotronics, LLC · Oct 9, 2026 · K261521

FDA cleared the Sleep Analysis Module from Neurotronics, LLC on Oct 9, 2026 under K261521, a traditional 510(k). The device falls under product code OLZ, Automatic Event Detection Software For Polysomnograph With Electroencephalograph, regulated at 21 CFR 882.1400 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on May 7, 2026. The decision came 155 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 Neurotronics, LLC in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K261521?

K261521 is the FDA 510(k) for Sleep Analysis Module, submitted by Neurotronics, LLC. FDA's decision date was Oct 9, 2026, under product code OLZ (Automatic Event Detection Software For Polysomnograph With Electroencephalograph).

Who makes the Sleep Analysis Module?

Neurotronics, LLC, based in Alachua, FL, is the applicant of record for K261521.

How long did the K261521 review take?

FDA received the submission on May 7, 2026 and issued its decision on Oct 9, 2026, 155 days later.

← All decisions in October 2026