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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 / K254123

510(k) cleared

Ecomed Disposable Administration Sets

Ecomed Solutions, LLC · Sep 11, 2026 · K254123

FDA cleared the Ecomed Disposable Administration Sets from Ecomed Solutions, LLC on Sep 11, 2026 under K254123, a abbreviated 510(k). The device falls under product code FPA, Set, Administration, Intravascular, regulated at 21 CFR 880.5440 as a Class 2 device. The review panel was General Hospital.

FDA logged the submission as received on Dec 19, 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 Ecomed Solutions, LLC in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K254123?

K254123 is the FDA 510(k) for Ecomed Disposable Administration Sets, submitted by Ecomed Solutions, LLC. FDA's decision date was Sep 11, 2026, under product code FPA (Set, Administration, Intravascular).

Who makes the Ecomed Disposable Administration Sets?

Ecomed Solutions, LLC, based in Lindenhurst, IL, is the applicant of record for K254123.

How long did the K254123 review take?

FDA received the submission on Dec 19, 2025 and issued its decision on Sep 11, 2026, 266 days later.

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