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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 / May 2026 / K252915

510(k) cleared

AiSteth®

Ai Health Highway India Pvt., Ltd. · May 22, 2026 · K252915

FDA cleared the AiSteth® from Ai Health Highway India Pvt., Ltd. on May 22, 2026 under K252915, 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 Sep 12, 2025. The decision came 252 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 Ai Health Highway India Pvt., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252915?

K252915 is the FDA 510(k) for AiSteth®, submitted by Ai Health Highway India Pvt., Ltd.. FDA's decision date was May 22, 2026, under product code DQD (Stethoscope, Electronic).

Who makes the AiSteth®?

Ai Health Highway India Pvt., Ltd., based in Bangalore, is the applicant of record for K252915.

How long did the K252915 review take?

FDA received the submission on Sep 12, 2025 and issued its decision on May 22, 2026, 252 days later.

← All decisions in May 2026