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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 / K254036

510(k) cleared

Novii+ Wireless Patch System

Datex Ohmeda, Inc. · Aug 10, 2026 · K254036

FDA cleared the Novii+ Wireless Patch System from Datex Ohmeda, Inc. on Aug 10, 2026 under K254036, a traditional 510(k). The device falls under product code HGM, System, Monitoring, Perinatal, regulated at 21 CFR 884.2740 as a Class 2 device. The review panel was Obstetrics/Gynecology.

FDA logged the submission as received on Dec 16, 2025. The decision came 237 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Datex Ohmeda, Inc. has 2 other decisions in the tracker over the last 12 months: K260326 (Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1)), K251663 (Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1)).

Questions & Answers

What did FDA clear under K254036?

K254036 is the FDA 510(k) for Novii+ Wireless Patch System, submitted by Datex Ohmeda, Inc.. FDA's decision date was Aug 10, 2026, under product code HGM (System, Monitoring, Perinatal).

Who makes the Novii+ Wireless Patch System?

Datex Ohmeda, Inc., based in Waukesha, WI, is the applicant of record for K254036.

How long did the K254036 review take?

FDA received the submission on Dec 16, 2025 and issued its decision on Aug 10, 2026, 237 days later.

← All decisions in August 2026

Sources