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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 / February 2026 / K251619

510(k) cleared

Babyleo TN500

Drägerwerk AG & Co. KGaA · Feb 13, 2026 · K251619

FDA cleared the Babyleo TN500 from Drägerwerk AG & Co. KGaA on Feb 13, 2026 under K251619, 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 27, 2025. The decision came 262 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Drägerwerk AG & Co. KGaA has 2 other decisions in the tracker over the last 12 months: K252746 (Atlan (A100); Atlan (A100 XL); Atlan(A350); Atlan (A350 XL)), K252827 (IBP cable Becton Dickinson (2606488); IBP cable Edwards (2606489); IBP cable Abbott, Medex (2606490); IBP cable Utah (2606491); IBP Adapter Cable Draeger 7pin (2607558); IBP Adapter Cable Draeger 10pin (2607559)).

Questions & Answers

What did FDA clear under K251619?

K251619 is the FDA 510(k) for Babyleo TN500, submitted by Drägerwerk AG & Co. KGaA. FDA's decision date was Feb 13, 2026, under product code FMZ (Incubator, Neonatal).

Who makes the Babyleo TN500?

Drägerwerk AG & Co. KGaA, based in Luebeck, is the applicant of record for K251619.

How long did the K251619 review take?

FDA received the submission on May 27, 2025 and issued its decision on Feb 13, 2026, 262 days later.

← All decisions in February 2026