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The Tracker / October 2026 / K262597

510(k) cleared

Access BNP II

Beckman Coulter, Inc. · Oct 20, 2026 · K262597

FDA cleared the Access BNP II from Beckman Coulter, Inc. on Oct 20, 2026 under K262597, 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 Jul 27, 2026. The decision came 85 days later, inside the 90 FDA-day goal for a 510(k).

Beckman Coulter, Inc. has 7 other decisions in the tracker over the last 12 months: K261109 (Access MeMed BV), K262109 (Access NT-proBNP), K252169 (Access BNP II), K254059 (Access anti-HBc IgM).

Questions & Answers

What did FDA clear under K262597?

K262597 is the FDA 510(k) for Access BNP II, submitted by Beckman Coulter, Inc.. FDA's decision date was Oct 20, 2026, under product code NBC (Test, Natriuretic Peptide).

Who makes the Access BNP II?

Beckman Coulter, Inc., based in Chaska, MN, is the applicant of record for K262597.

How long did the K262597 review take?

FDA received the submission on Jul 27, 2026 and issued its decision on Oct 20, 2026, 85 days later.

← All decisions in October 2026

Sources