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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 / August 2026 / K261061

510(k) cleared

BP Go (BPP-855)

Wellvii, Inc. · Aug 13, 2026 · K261061

FDA cleared the BP Go (BPP-855) from Wellvii, Inc. on Aug 13, 2026 under K261061, 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 Mar 31, 2026. The decision came 135 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 Wellvii, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K261061?

K261061 is the FDA 510(k) for BP Go (BPP-855), submitted by Wellvii, Inc.. FDA's decision date was Aug 13, 2026, under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive).

Who makes the BP Go (BPP-855)?

Wellvii, Inc., based in Palm Beach Gardens, FL, is the applicant of record for K261061.

How long did the K261061 review take?

FDA received the submission on Mar 31, 2026 and issued its decision on Aug 13, 2026, 135 days later.

← All decisions in August 2026