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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 / May 2026 / K253152

510(k) cleared

BP1000 Ultra-Compact Fingertip Blood Pressure Monitor (BP1000)

Biozen, LLC · May 6, 2026 · K253152

FDA cleared the BP1000 Ultra-Compact Fingertip Blood Pressure Monitor (BP1000) from Biozen, LLC on May 6, 2026 under K253152, a traditional 510(k). The device falls under product code DXN, System, Measurement, Blood-Pressure, Non-Invasive, regulated at 21 CFR 870.1130 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Sep 26, 2025. The decision came 222 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Biozen, LLC in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253152?

K253152 is the FDA 510(k) for BP1000 Ultra-Compact Fingertip Blood Pressure Monitor (BP1000), submitted by Biozen, LLC. FDA's decision date was May 6, 2026, under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive).

Who makes the BP1000 Ultra-Compact Fingertip Blood Pressure Monitor (BP1000)?

Biozen, LLC, based in Oklahoma City, OK, is the applicant of record for K253152.

How long did the K253152 review take?

FDA received the submission on Sep 26, 2025 and issued its decision on May 6, 2026, 222 days later.

← All decisions in May 2026