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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 / July 2026 / K261694

510(k) cleared

CORE 300 Digital Stethoscope

Eko Health, Inc. · Jul 23, 2026 · K261694

FDA cleared the CORE 300 Digital Stethoscope from Eko Health, Inc. on Jul 23, 2026 under K261694, 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 May 22, 2026. The decision came 62 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Eko Health, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K261694?

K261694 is the FDA 510(k) for CORE 300 Digital Stethoscope, submitted by Eko Health, Inc.. FDA's decision date was Jul 23, 2026, under product code DQD (Stethoscope, Electronic).

Who makes the CORE 300 Digital Stethoscope?

Eko Health, Inc., based in Emeryville, CA, is the applicant of record for K261694.

How long did the K261694 review take?

FDA received the submission on May 22, 2026 and issued its decision on Jul 23, 2026, 62 days later.

← All decisions in July 2026