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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 / October 2025 / K251663

510(k) cleared

Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1)

Datex-Ohmeda, Inc. · Oct 22, 2025 · K251663

FDA cleared the Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1) from Datex-Ohmeda, Inc. on Oct 22, 2025 under K251663, a traditional 510(k). The device falls under product code FMZ, Incubator, Neonatal, regulated at 21 CFR 880.5400 as a Class 2 device. The review panel was General Hospital.

FDA logged the submission as received on May 30, 2025. The decision came 145 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: K254036 (Novii+ Wireless Patch System), K260326 (Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1)).

Questions & Answers

What did FDA clear under K251663?

K251663 is the FDA 510(k) for Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1), submitted by Datex-Ohmeda, Inc.. FDA's decision date was Oct 22, 2025, under product code FMZ (Incubator, Neonatal).

Who makes the Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1)?

Datex-Ohmeda, Inc., based in Wauwatosa, WI, is the applicant of record for K251663.

How long did the K251663 review take?

FDA received the submission on May 30, 2025 and issued its decision on Oct 22, 2025, 145 days later.

← All decisions in October 2025

Sources