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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 / K260075

510(k) cleared

eClinics

Ceiba Healthcare US, Inc. · Oct 7, 2026 · K260075

FDA cleared the eClinics from Ceiba Healthcare US, Inc. on Oct 7, 2026 under K260075, a traditional 510(k). The device falls under product code MSX, System, Network And Communication, Physiological Monitors, regulated at 21 CFR 870.2300 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Jan 12, 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 Ceiba Healthcare US, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260075?

K260075 is the FDA 510(k) for eClinics, submitted by Ceiba Healthcare US, Inc.. FDA's decision date was Oct 7, 2026, under product code MSX (System, Network And Communication, Physiological Monitors).

Who makes the eClinics?

Ceiba Healthcare US, Inc., based in New York, NY, is the applicant of record for K260075.

How long did the K260075 review take?

FDA received the submission on Jan 12, 2026 and issued its decision on Oct 7, 2026, 268 days later.

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