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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 / November 2025 / K251631

510(k) cleared

The BAG manual resuscitator and accessories

Laerdal Medical AS · Nov 24, 2025 · K251631

FDA cleared the The BAG manual resuscitator and accessories from Laerdal Medical AS on Nov 24, 2025 under K251631, a traditional 510(k). The device falls under product code BTM, Ventilator, Emergency, Manual (Resuscitator), regulated at 21 CFR 868.5915 as a Class 2 device. The review panel was Anesthesiology.

FDA logged the submission as received on May 28, 2025. The decision came 180 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Laerdal Medical AS in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251631?

K251631 is the FDA 510(k) for The BAG manual resuscitator and accessories, submitted by Laerdal Medical AS. FDA's decision date was Nov 24, 2025, under product code BTM (Ventilator, Emergency, Manual (Resuscitator)).

Who makes the The BAG manual resuscitator and accessories?

Laerdal Medical AS, based in Stavanger, is the applicant of record for K251631.

How long did the K251631 review take?

FDA received the submission on May 28, 2025 and issued its decision on Nov 24, 2025, 180 days later.

← All decisions in November 2025