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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 / K254074

510(k) cleared

TruPress

Procerus Enterprises · Sep 10, 2026 · K254074

FDA cleared the TruPress from Procerus Enterprises on Sep 10, 2026 under K254074, a traditional 510(k). The device falls under product code DRS, Transducer, Blood-Pressure, Extravascular, regulated at 21 CFR 870.2850 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Dec 18, 2025. The decision came 266 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 Procerus Enterprises in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K254074?

K254074 is the FDA 510(k) for TruPress, submitted by Procerus Enterprises. FDA's decision date was Sep 10, 2026, under product code DRS (Transducer, Blood-Pressure, Extravascular).

Who makes the TruPress?

Procerus Enterprises, based in Salt Lake City, UT, is the applicant of record for K254074.

How long did the K254074 review take?

FDA received the submission on Dec 18, 2025 and issued its decision on Sep 10, 2026, 266 days later.

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