Cleared Traditional

K240901 - Stethophone

K240901 is an FDA 510(k) clearance for Stethophone, manufactured by Sparrow Acoustics, Inc.. The device is a Class 2 Cardiovascular device with product code DQD cleared through the Traditional 510(k) pathway after a 170-day FDA review.

K240901 · Sparrow Acoustics, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2024
Decision
170d
Days
Class 2
Risk

K240901 is an FDA 510(k) clearance for the Stethophone. Classified as Stethoscope, Electronic (product code DQD), Class II - Special Controls.

Submitted by Sparrow Acoustics, Inc. (Lucasville, CA). The FDA issued a Cleared decision on September 19, 2024 after a review of 170 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1875 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Sparrow Acoustics, Inc. devices

FDA 510(k) Submission Details - K240901

510(k) Number K240901 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 2024
Decision Date September 19, 2024
Days to Decision 170 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
45d slower than avg
Panel avg: 125d · This submission: 170d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQD Device Classification - Class 2, Special Controls

Product Code DQD Stethoscope, Electronic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1875
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DQD Stethoscope, Electronic

All 58
Devices cleared under the same product code (DQD) and FDA review panel - the closest regulatory comparables to K240901.
Stethophone Pro
K252595 · Sparrow Acoustics, Inc. · Sep 2025
Eko Foundation Analysis Software with Transformers (EFAST)
K251494 · Eko Health, Inc. · Aug 2025
AccurSound Electronic Stethoscope (AS101)
K242971 · Heroic Faith International , Ltd. · Nov 2024
Keikku Electronic stethoscope
K233313 · Lapsi Health Holding B.V. · Apr 2024
CORE 500 Digital Stethoscope
K233609 · Eko Health, Inc. · Mar 2024
Stethophone
K231551 · Sparrow Acoustics, Inc. · Oct 2023