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GE HealthCare clears aortic stenosis and lung scanning software for Vscan Air FDA draws more than 500 comments on its generative AI device framework BRIJ Medical upsizes a $3M raise to $5M for its incision management line Globus Medical bought Synaptive Medical out of receivership in August Philips sets aside 288 million euros for a proposed DOJ settlement over its CPAP recall Rockwell Medical agrees to buy most of Vantive's hemodialysis business Blackstone puts $455M into Boston Scientific's VITALYST heart pump program 1nhaler raises £2.2M to take a cardboard inhaler into the clinic ONWARD Medical sold 88 ARC-EX systems in the third quarter GE HealthCare clears aortic stenosis and lung scanning software for Vscan Air FDA draws more than 500 comments on its generative AI device framework BRIJ Medical upsizes a $3M raise to $5M for its incision management line Globus Medical bought Synaptive Medical out of receivership in August Philips sets aside 288 million euros for a proposed DOJ settlement over its CPAP recall Rockwell Medical agrees to buy most of Vantive's hemodialysis business Blackstone puts $455M into Boston Scientific's VITALYST heart pump program 1nhaler raises £2.2M to take a cardboard inhaler into the clinic ONWARD Medical sold 88 ARC-EX systems in the third quarter

The Tracker / October 2026 / K261109

510(k) cleared

Access MeMed BV

Beckman Coulter, Inc. · Oct 19, 2026 · K261109

FDA cleared the Access MeMed BV from Beckman Coulter, Inc. on Oct 19, 2026 under K261109, a traditional 510(k). The device falls under product code QPS, Immunoassay For Host Biomarkers Of Infection, regulated at 21 CFR 866.3215 as a Class 2 device. The review panel was Microbiology.

FDA logged the submission as received on Apr 3, 2026. The decision came 199 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Beckman Coulter, Inc. has 7 other decisions in the tracker over the last 12 months: K262597 (Access BNP II), K262109 (Access NT-proBNP), K252169 (Access BNP II), K254059 (Access anti-HBc IgM).

Questions & Answers

What did FDA clear under K261109?

K261109 is the FDA 510(k) for Access MeMed BV, submitted by Beckman Coulter, Inc.. FDA's decision date was Oct 19, 2026, under product code QPS (Immunoassay For Host Biomarkers Of Infection).

Who makes the Access MeMed BV?

Beckman Coulter, Inc., based in Chaska, MN, is the applicant of record for K261109.

How long did the K261109 review take?

FDA received the submission on Apr 3, 2026 and issued its decision on Oct 19, 2026, 199 days later.

← All decisions in October 2026

Sources