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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 / December 2025 / K252284

510(k) cleared

eMurmur Heart AI

Csd Labs · Dec 19, 2025 · K252284

FDA cleared the eMurmur Heart AI from Csd Labs on Dec 19, 2025 under K252284, a traditional 510(k). The device falls under product code DQD, Stethoscope, Electronic, regulated at 21 CFR 870.1875 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Jul 22, 2025. The decision came 150 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 Csd Labs in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252284?

K252284 is the FDA 510(k) for eMurmur Heart AI, submitted by Csd Labs. FDA's decision date was Dec 19, 2025, under product code DQD (Stethoscope, Electronic).

Who makes the eMurmur Heart AI?

Csd Labs, based in Graz, is the applicant of record for K252284.

How long did the K252284 review take?

FDA received the submission on Jul 22, 2025 and issued its decision on Dec 19, 2025, 150 days later.

← All decisions in December 2025