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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 / May 2026 / K252746

510(k) cleared

Atlan (A100); Atlan (A100 XL); Atlan(A350); Atlan (A350 XL)

Drägerwerk AG Co. Kgaa · May 21, 2026 · K252746

FDA cleared the Atlan (A100); Atlan (A100 XL); Atlan(A350); Atlan (A350 XL) from Drägerwerk AG Co. Kgaa on May 21, 2026 under K252746, a traditional 510(k). The device falls under product code BSZ, Gas-Machine, Anesthesia, regulated at 21 CFR 868.5160 as a Class 2 device. The review panel was Anesthesiology.

FDA logged the submission as received on Aug 29, 2025. The decision came 265 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: K251619 (Babyleo TN500), 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 K252746?

K252746 is the FDA 510(k) for Atlan (A100); Atlan (A100 XL); Atlan(A350); Atlan (A350 XL), submitted by Drägerwerk AG Co. Kgaa. FDA's decision date was May 21, 2026, under product code BSZ (Gas-Machine, Anesthesia).

Who makes the Atlan (A100); Atlan (A100 XL); Atlan(A350); Atlan (A350 XL)?

Drägerwerk AG Co. Kgaa, based in Lübeck, is the applicant of record for K252746.

How long did the K252746 review take?

FDA received the submission on Aug 29, 2025 and issued its decision on May 21, 2026, 265 days later.

← All decisions in May 2026

Sources