510(k) · Cleared
ClearedStethophone Pro
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sparrow Acoustics, Inc. · DQD Stethoscope, Electronic
Cleared on Sep 12, 2025 as substantially equivalent to K240901 (Sparrow Acoustics, Inc., 2024) after a 28-day review. Its family tree reaches back 14 generations to 1991.
- Decided
- Sep 12, 2025
- Review
- 28 days
- Class
- Class II
- Product code
- DQD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 14 generations to K910772 (1991). 122 ancestors in all, the oldest K771653 (1977). No later device cites it as a predicate yet.
- Root · 14 generations backK910772 Propaq 102, 104 and 106Protocol Systems, Inc. · 1991
- 10 generations between
- 3 generations backK181988 eMurmur IDCsd Labs GmbH · 2019
- 2 generations backK213794 Eko Murmur Analysis Software (EMAS)Eko Devices, Inc. · 2022
- 1 generation backK240901 StethophoneSparrow Acoustics, Inc. · 2024
- This deviceK252595 Stethophone ProSparrow Acoustics, Inc. · 2025
Show all 14 generations
- Root · 14 generations backK910772 Propaq 102, 104 and 106Protocol Systems, Inc. · 1991
- 13 generations backK972020 Oscillomate Non-Invasive Blood Pressure MonitorCas Medical Systems, Inc. · 1998
- 12 generations backK980879 Oscillomate Nibp / SP02 Ems MonitorCas Medical Systems, Inc. · 1998
- 11 generations backK982776 9303 Neonatal/Adult Vital Signs MonitorCas Medical Systems, Inc. · 1998
- 10 generations backK013319 Nonin Model 2120 Pulse Oximeter and Noninvasive Blood Pressure…Nonin Medical, Inc. · 2002
- 9 generations backK041156 Avant Digital Pulse Oximetry System, Models 4000, 4001Nonin Medical, Inc. · 2004 · Recalled
- 8 generations backK043359 4100 Patient Oximeter ModuleNonin Medical, Inc. · 2005
- 7 generations backK083309 Zargis Acoustic Cardioscan, Version 9.33Zargis Medical Corp. · 2009
- 6 generations backK110704 SENSIDiacoustic Medical Devices (Pty), Ltd. · 2011
- 5 generations backK121617 SensicardiacDiacoustic Medical (Pty) · 2012
- 4 generations backK131044 Sensicardiac Mobi Diagnostic Heart Murmur ApplicationDiacoustic Medical Devices (Pty), Ltd. · 2013
- 3 generations backK181988 eMurmur IDCsd Labs GmbH · 2019
- 2 generations backK213794 Eko Murmur Analysis Software (EMAS)Eko Devices, Inc. · 2022
- 1 generation backK240901 StethophoneSparrow Acoustics, Inc. · 2024
- This deviceK252595 Stethophone ProSparrow Acoustics, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K910772 | Propaq 102, 104 and 106 | Protocol Systems, Inc. | 1991 | — |
| −13 | K972020 | Oscillomate Non-Invasive Blood Pressure Monitor | Cas Medical Systems, Inc. | 1998 | — |
| −12 | K980879 | Oscillomate Nibp / SP02 Ems Monitor | Cas Medical Systems, Inc. | 1998 | — |
| −11 | K982776 | 9303 Neonatal/Adult Vital Signs Monitor | Cas Medical Systems, Inc. | 1998 | — |
| −10 | K013319 | Nonin Model 2120 Pulse Oximeter and Noninvasive Blood Pressure (Nibp) Monitor | Nonin Medical, Inc. | 2002 | — |
| −9 | K041156 | Avant Digital Pulse Oximetry System, Models 4000, 4001 | Nonin Medical, Inc. | 2004 | 1 |
| −8 | K043359 | 4100 Patient Oximeter Module | Nonin Medical, Inc. | 2005 | — |
| −7 | K083309 | Zargis Acoustic Cardioscan, Version 9.33 | Zargis Medical Corp. | 2009 | — |
| −6 | K110704 | SENSI | Diacoustic Medical Devices (Pty), Ltd. | 2011 | — |
| −5 | K121617 | Sensicardiac | Diacoustic Medical (Pty) | 2012 | — |
| −4 | K131044 | Sensicardiac Mobi Diagnostic Heart Murmur Application | Diacoustic Medical Devices (Pty), Ltd. | 2013 | — |
| −3 | K181988 | eMurmur ID | Csd Labs GmbH | 2019 | — |
| −2 | K213794 | Eko Murmur Analysis Software (EMAS) | Eko Devices, Inc. | 2022 | — |
| −1 | K240901 | Stethophone | Sparrow Acoustics, Inc. | 2024 | — |
| 0 (this device) | K252595 | Stethophone Pro | Sparrow Acoustics, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1977 | 1 | 0 |
| 1986 | 1 | 0 |
| 1987 | 3 | 0 |
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 4 | 0 |
| 1993 | 3 | 0 |
| 1994 | 3 | 0 |
| 1995 | 4 | 0 |
| 1996 | 10 | 0 |
| 1997 | 7 | 0 |
| 1998 | 7 | 0 |
| 1999 | 3 | 0 |
| 2000 | 6 | 0 |
| 2001 | 6 | 0 |
| 2002 | 5 | 0 |
| 2003 | 2 | 0 |
| 2004 | 6 | 0 |
| 2005 | 6 | 0 |
| 2006 | 2 | 0 |
| 2007 | 5 | 0 |
| 2008 | 3 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 3 | 0 |
| 2017 | 1 | 0 |
| 2018 | 3 | 0 |
| 2020 | 2 | 0 |
| 2023 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DQD? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DQD device
- #1 K200776 Eko COREscore 25.2 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K240901 | StethophoneSummary page 6…w Starling Filter for listening to the full frequency of chest sounds All of these features are present in both the primary predicate, Stethophone Pro (K240901), and the reference device, Stethophone (K231551), and are now available for OTC use. Product Features… | 2024 |
| † | K231551 | Stethophone | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 34 years and passes through 9 companies; a new generation was cleared every 2.4 years on median.
- 4 of the 122 ancestors have a recall of any class.
How does its category compare?
All DQD devicesDQD Stethoscope, Electronic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · DQD
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQD
89in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQD
No recall names DQD since 2007.
Adverse event reports per year · DQD
1in 2024
MAUDE reports naming product code DQD, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 6 | 161 | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 4 | 107 | 0 | 1 |
| 2012 | 2 | — | 0 | 0 |
| 2013 | 5 | 70 | 0 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 2 | — | 0 | 0 |
| 2016 | 3 | 250 | 0 | 0 |
| 2017 | 4 | 109 | 0 | 0 |
| 2018 | 4 | 131 | 0 | 0 |
| 2019 | 4 | 262 | 0 | 0 |
| 2020 | 6 | 104 | 0 | 0 |
| 2021 | 4 | 137 | 0 | 0 |
| 2022 | 8 | 203 | 0 | 0 |
| 2023 | 10 | 132 | 0 | 0 |
| 2024 | 4 | 153 | 0 | 1 |
| 2025 | 3 | 89 | 0 | 0 |
| 2026 | 6 | 236 | 0 | — |
What is it indicated for?
Stethophone Pro is an electronic stethoscope that enables detection, amplification, filtering, and transmission of auscultation sound data (heart and lungs), whereby a clinician at one location can listen to the auscultation sounds of a patient acquired on site or at a different location. Stethophone Pro is intended for use on adult patients. Stethophone Pro is not intended for self-diagnosis and not intended to be used as a sole means of diagnosis.…
Read the full statement (195 words)
Stethophone Pro is an electronic stethoscope that enables detection, amplification, filtering, and transmission of auscultation sound data (heart and lungs), whereby a clinician at one location can listen to the auscultation sounds of a patient acquired on site or at a different location. Stethophone Pro is intended for use on adult patients. Stethophone Pro is not intended for self-diagnosis and not intended to be used as a sole means of diagnosis. Stethophone Pro can be used in clinical and nonclinical environments.
For Rx-only: Stethophone Pro is intended to provide decision support to clinicians in their evaluation of patients' heart sounds. The software analyzes heart sounds and phonocardiograms and can automatically detect murmurs that may be present, sound timing and character, including S1, S2, and the absence of a heart murmur. The interpretations of heart sounds offered by the software are not diagnoses and are meant only to provide decision support to the clinician, who may use the result in conjunction with their own evaluation and clinical judgment.
For OTC: When used without access to the automatic analysis results or under supervision of healthcare professional, Stethophone Pro is also intended to be used by lay users.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252595 · printed Nov 6, 2026
Cite this page
510(k) Report. “K252595: Stethophone Pro.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K252595
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026