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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 / K261470

510(k) cleared

PurGuard360(QF10)

E.A.M Benelux B.V · Sep 9, 2026 · K261470

FDA cleared the PurGuard360(QF10) from E.A.M Benelux B.V on Sep 9, 2026 under K261470, a traditional 510(k). The device falls under product code NHV, System, Water Purification, General Medical Use, regulated at 21 CFR 876.5665 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on May 4, 2026. The decision came 128 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 E.A.M Benelux B.V in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K261470?

K261470 is the FDA 510(k) for PurGuard360(QF10), submitted by E.A.M Benelux B.V. FDA's decision date was Sep 9, 2026, under product code NHV (System, Water Purification, General Medical Use).

Who makes the PurGuard360(QF10)?

E.A.M Benelux B.V, based in Almere, is the applicant of record for K261470.

How long did the K261470 review take?

FDA received the submission on May 4, 2026 and issued its decision on Sep 9, 2026, 128 days later.

← All decisions in September 2026