WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Exit Postmarket & security

THE TAPE

FDA approves Cordis Selution SLR, the first sirolimus drug-eluting balloon sold in the US FDA panel takes up GRAIL's Galleri cancer screening PMA on September 23 FDA folds the human factors guidance into eSTAR 7.1 and widens PreSTAR to five more meeting types AVAVA raises $45M with a third of it in debt from its lead investor UpFront Diagnostics wins a CE mark for a 10-minute stroke blood test Ambu pays $45M upfront for TIMS Medical and about 7,000 US hospital installs Citi downgrades Boston Scientific over the cyberattack recovery Autonomix puts Medtronic's former chief regulatory counsel on its board FDA calls the NOxBOXi oxygen leak fix a Class II correction, three years after a Class I recall FDA approves Cordis Selution SLR, the first sirolimus drug-eluting balloon sold in the US FDA panel takes up GRAIL's Galleri cancer screening PMA on September 23 FDA folds the human factors guidance into eSTAR 7.1 and widens PreSTAR to five more meeting types AVAVA raises $45M with a third of it in debt from its lead investor UpFront Diagnostics wins a CE mark for a 10-minute stroke blood test Ambu pays $45M upfront for TIMS Medical and about 7,000 US hospital installs Citi downgrades Boston Scientific over the cyberattack recovery Autonomix puts Medtronic's former chief regulatory counsel on its board FDA calls the NOxBOXi oxygen leak fix a Class II correction, three years after a Class I recall

The Tracker / September 2026 / K261287

510(k) cleared

Digistat Care

Ascom Ums Srl Unipersonale · Sep 12, 2026 · K261287

FDA cleared the Digistat Care from Ascom Ums Srl Unipersonale on Sep 12, 2026 under K261287, 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 Apr 20, 2026. The decision came 145 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 Ascom Ums Srl Unipersonale in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K261287?

K261287 is the FDA 510(k) for Digistat Care, submitted by Ascom Ums Srl Unipersonale. FDA's decision date was Sep 12, 2026, under product code MSX (System, Network And Communication, Physiological Monitors).

Who makes the Digistat Care?

Ascom Ums Srl Unipersonale, based in Scandicci (Fi), is the applicant of record for K261287.

How long did the K261287 review take?

FDA received the submission on Apr 20, 2026 and issued its decision on Sep 12, 2026, 145 days later.

← All decisions in September 2026