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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 / December 2025 / K252827

510(k) cleared

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)

Drägerwerk AG & Co. KGaA · Dec 1, 2025 · K252827

FDA cleared the 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) from Drägerwerk AG & Co. KGaA on Dec 1, 2025 under K252827, a traditional 510(k). The device falls under product code DSA, Cable, Transducer And Electrode, Patient, (Including Connector), regulated at 21 CFR 870.2900 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Sep 5, 2025. The decision came 87 days later, inside the 90 FDA-day goal for a 510(k).

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)), K251619 (Babyleo TN500).

Questions & Answers

What did FDA clear under K252827?

K252827 is the FDA 510(k) for 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), submitted by Drägerwerk AG & Co. KGaA. FDA's decision date was Dec 1, 2025, under product code DSA (Cable, Transducer And Electrode, Patient, (Including Connector)).

Who makes the 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)?

Drägerwerk AG & Co. KGaA, based in Luebeck, is the applicant of record for K252827.

How long did the K252827 review take?

FDA received the submission on Sep 5, 2025 and issued its decision on Dec 1, 2025, 87 days later.

← All decisions in December 2025

Sources