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The Tracker / September 2026 / K262109

510(k) cleared

Access NT-proBNP

Beckman Coulter, Inc. · Sep 21, 2026 · K262109

FDA cleared the Access NT-proBNP from Beckman Coulter, Inc. on Sep 21, 2026 under K262109, a traditional 510(k). The device falls under product code NBC, Test, Natriuretic Peptide, regulated at 21 CFR 862.1117 as a Class 2 device. The review panel was Clinical Chemistry.

FDA logged the submission as received on Jun 23, 2026. The decision came 90 days later, inside the 90 FDA-day goal for a 510(k).

Beckman Coulter, Inc. has 5 other decisions in the tracker over the last 12 months: K252169 (Access BNP II), K254059 (Access anti-HBc IgM), K253687 (Access anti-HBc Total), K251995 (Access anti-HAV IgM).

Questions & Answers

What did FDA clear under K262109?

K262109 is the FDA 510(k) for Access NT-proBNP, submitted by Beckman Coulter, Inc.. FDA's decision date was Sep 21, 2026, under product code NBC (Test, Natriuretic Peptide).

Who makes the Access NT-proBNP?

Beckman Coulter, Inc., based in Chaska, MN, is the applicant of record for K262109.

How long did the K262109 review take?

FDA received the submission on Jun 23, 2026 and issued its decision on Sep 21, 2026, 90 days later.

← All decisions in September 2026

Sources