WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

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 / November 2025 / K252474

510(k) cleared

Withings BeamO (SCT02)

Withings · Nov 10, 2025 · K252474

FDA cleared the Withings BeamO (SCT02) from Withings on Nov 10, 2025 under K252474, a traditional 510(k). The device falls under product code DPS, Electrocardiograph, regulated at 21 CFR 870.2340 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Aug 6, 2025. The decision came 96 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 Withings in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252474?

K252474 is the FDA 510(k) for Withings BeamO (SCT02), submitted by Withings. FDA's decision date was Nov 10, 2025, under product code DPS (Electrocardiograph).

Who makes the Withings BeamO (SCT02)?

Withings, based in Issy-Les-Moulineaux, is the applicant of record for K252474.

How long did the K252474 review take?

FDA received the submission on Aug 6, 2025 and issued its decision on Nov 10, 2025, 96 days later.

← All decisions in November 2025