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Medtronic pays about $700M for rights to sell Cornerstone Robotics' Sentire outside the US Globus Medical wins a CE mark for Excelsius3D five years after FDA clearance GE HealthCare software updates dropped patients from monitoring, now a Class II recall Boston Scientific pulls Imager II catheters over degrading tips and ends the product line MiniMed wins a CE mark for the Flex insulin pump ahead of its year-end target Boston Scientific restarts shipping a week after the August 25 cyberattack ArthroTAK gets a second 510(k), adding knee tenodesis to its sutureless tendon anchor Oura files S-1 for Nasdaq IPO with $1.21B in nine-month revenue and 5 million paid members FDA confirms a Class I recall of Boston Scientific Infinion CX leads after 1,081 serious injuries Medtronic pays about $700M for rights to sell Cornerstone Robotics' Sentire outside the US Globus Medical wins a CE mark for Excelsius3D five years after FDA clearance GE HealthCare software updates dropped patients from monitoring, now a Class II recall Boston Scientific pulls Imager II catheters over degrading tips and ends the product line MiniMed wins a CE mark for the Flex insulin pump ahead of its year-end target Boston Scientific restarts shipping a week after the August 25 cyberattack ArthroTAK gets a second 510(k), adding knee tenodesis to its sutureless tendon anchor Oura files S-1 for Nasdaq IPO with $1.21B in nine-month revenue and 5 million paid members FDA confirms a Class I recall of Boston Scientific Infinion CX leads after 1,081 serious injuries

The Tracker / August 2026 / K261466

510(k) cleared

Alegria Flash MPO; Alegria Flash PR3; Alegria Flash GBM

Zeus Scientific · Aug 21, 2026 · K261466

FDA cleared the Alegria Flash MPO; Alegria Flash PR3; Alegria Flash GBM from Zeus Scientific on Aug 21, 2026 under K261466, a traditional 510(k). The device falls under product code MOB, Test System, Antineutrophil Cytoplasmic Antibodies (Anca), regulated at 21 CFR 866.5660 as a Class 2 device. The review panel was Immunology.

FDA logged the submission as received on May 4, 2026. The decision came 109 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Zeus Scientific has 3 other decisions in the tracker over the last 12 months: K250814 (Alegria Flash SSA-60; Alegria Flash SSA-52; Alegria FLash SSB), K250666 (Alegria Flash CTD Screen), K250408 (Alegria Flash ENA Screen).

Questions & Answers

What did FDA clear under K261466?

K261466 is the FDA 510(k) for Alegria Flash MPO; Alegria Flash PR3; Alegria Flash GBM, submitted by Zeus Scientific. FDA's decision date was Aug 21, 2026, under product code MOB (Test System, Antineutrophil Cytoplasmic Antibodies (Anca)).

Who makes the Alegria Flash MPO; Alegria Flash PR3; Alegria Flash GBM?

Zeus Scientific, based in Branchburg, NJ, is the applicant of record for K261466.

How long did the K261466 review take?

FDA received the submission on May 4, 2026 and issued its decision on Aug 21, 2026, 109 days later.

← All decisions in August 2026

Sources