WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

THE TAPE

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 / December 2025 / K232365

510(k) cleared

Vivo 45 LS

Oconnell Regulatory Consultants, Inc. · Dec 19, 2025 · K232365

FDA cleared the Vivo 45 LS from Oconnell Regulatory Consultants, Inc. on Dec 19, 2025 under K232365, a traditional 510(k). The device falls under product code CBK, Ventilator, Continuous, Facility Use, regulated at 21 CFR 868.5895 as a Class 2 device. The review panel was Anesthesiology.

FDA logged the submission as received on Aug 7, 2023. The decision came 865 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 Oconnell Regulatory Consultants, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K232365?

K232365 is the FDA 510(k) for Vivo 45 LS, submitted by Oconnell Regulatory Consultants, Inc.. FDA's decision date was Dec 19, 2025, under product code CBK (Ventilator, Continuous, Facility Use).

Who makes the Vivo 45 LS?

Oconnell Regulatory Consultants, Inc., based in Stoneham, MA, is the applicant of record for K232365.

How long did the K232365 review take?

FDA received the submission on Aug 7, 2023 and issued its decision on Dec 19, 2025, 865 days later.

← All decisions in December 2025