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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 / September 2025 / K252595

510(k) cleared

Stethophone Pro

Sparrow Acoustics, Inc. · Sep 12, 2025 · K252595

FDA cleared the Stethophone Pro from Sparrow Acoustics, Inc. on Sep 12, 2025 under K252595, a special 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 Aug 15, 2025. The decision came 28 days later, inside the 90 FDA-day goal for a 510(k).

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

Questions & Answers

What did FDA clear under K252595?

K252595 is the FDA 510(k) for Stethophone Pro, submitted by Sparrow Acoustics, Inc.. FDA's decision date was Sep 12, 2025, under product code DQD (Stethoscope, Electronic).

Who makes the Stethophone Pro?

Sparrow Acoustics, Inc., based in Lucasville, is the applicant of record for K252595.

How long did the K252595 review take?

FDA received the submission on Aug 15, 2025 and issued its decision on Sep 12, 2025, 28 days later.

← All decisions in September 2025