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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / March 2026 / K252169

510(k) cleared

Access BNP II

Beckman Coulter, Inc. · Mar 24, 2026 · K252169

FDA cleared the Access BNP II from Beckman Coulter, Inc. on Mar 24, 2026 under K252169, 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 10, 2025. The decision came 257 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Beckman Coulter, Inc. has 6 other decisions in the tracker over the last 12 months: K254059 (Access anti-HBc IgM), K253687 (Access anti-HBc Total), K251995 (Access anti-HAV IgM), K250588 (Access Rubella IgG).

Questions & Answers

What did FDA clear under K252169?

K252169 is the FDA 510(k) for Access BNP II, submitted by Beckman Coulter, Inc.. FDA's decision date was Mar 24, 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 K252169.

How long did the K252169 review take?

FDA received the submission on Jul 10, 2025 and issued its decision on Mar 24, 2026, 257 days later.

← All decisions in March 2026

Sources