Cleared Traditional

K231551 - Stethophone

K231551 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 135-day FDA review.

K231551 · Sparrow Acoustics, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2023
Decision
135d
Days
Class 2
Risk

K231551 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 October 12, 2023 after a review of 135 days - within the typical 510(k) review window.

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 - K231551

510(k) Number K231551 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 2023
Decision Date October 12, 2023
Days to Decision 135 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
10d slower than avg
Panel avg: 125d · This submission: 135d
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 K231551.
Stethophone
K240901 · Sparrow Acoustics, Inc. · Sep 2024
Keikku Electronic stethoscope
K233313 · Lapsi Health Holding B.V. · Apr 2024
CORE 500 Digital Stethoscope
K233609 · Eko Health, Inc. · Mar 2024
SKEEPER
K230613 · Smartsound Corporation · Aug 2023
AusculThing ACC
K230823 · Ausculthing OY · Jul 2023
CORE 500 Digital Stethoscope
K230111 · Eko Devices, Inc. · May 2023