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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 / August 2026 / K260944

510(k) cleared

ManaCold Compression System

Manamed, LLC · Aug 12, 2026 · K260944

FDA cleared the ManaCold Compression System from Manamed, LLC on Aug 12, 2026 under K260944, a traditional 510(k). The device falls under product code IRP, Massager, Powered Inflatable Tube, regulated at 21 CFR 890.5650 as a Class 2 device. The review panel was Physical Medicine.

FDA logged the submission as received on Mar 23, 2026. The decision came 142 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 Manamed, LLC in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260944?

K260944 is the FDA 510(k) for ManaCold Compression System, submitted by Manamed, LLC. FDA's decision date was Aug 12, 2026, under product code IRP (Massager, Powered Inflatable Tube).

Who makes the ManaCold Compression System?

Manamed, LLC, based in Denton, TX, is the applicant of record for K260944.

How long did the K260944 review take?

FDA received the submission on Mar 23, 2026 and issued its decision on Aug 12, 2026, 142 days later.

← All decisions in August 2026