Cleared Special

Stethophone Pro

K252595 · Sparrow Acoustics, Inc. · Cardiovascular

Sep 2025

Decision

28d

Days

Class 2

Risk

About This 510(k) Submission

K252595 is an FDA 510(k) clearance for the Stethophone Pro, a Stethoscope, Electronic (Class II — Special Controls, product code DQD), submitted by Sparrow Acoustics, Inc. (Lucasville, CA). The FDA issued a Cleared decision on September 12, 2025, 28 days after receiving the submission on August 15, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1875.

Submission Details

510(k) Number	K252595 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 15, 2025
Decision Date	September 12, 2025
Days to Decision	28 days
Submission Type	Special
Review Panel	Cardiovascular (CV)
Summary	Summary PDF