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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 / September 2025 / K243926

510(k) cleared

Vivatmo pro-S

Bosch Healthcare Solutions GmbH · Sep 11, 2025 · K243926

FDA cleared the Vivatmo pro-S from Bosch Healthcare Solutions GmbH on Sep 11, 2025 under K243926, a traditional 510(k). The device falls under product code MXA, System, Test, Breath Nitric Oxide, regulated at 21 CFR 862.3080 as a Class 2 device. The review panel was Clinical Toxicology.

FDA logged the submission as received on Dec 20, 2024. The decision came 265 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 Bosch Healthcare Solutions GmbH in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K243926?

K243926 is the FDA 510(k) for Vivatmo pro-S, submitted by Bosch Healthcare Solutions GmbH. FDA's decision date was Sep 11, 2025, under product code MXA (System, Test, Breath Nitric Oxide).

Who makes the Vivatmo pro-S?

Bosch Healthcare Solutions GmbH, based in Waiblingen, is the applicant of record for K243926.

How long did the K243926 review take?

FDA received the submission on Dec 20, 2024 and issued its decision on Sep 11, 2025, 265 days later.

← All decisions in September 2025