510(k) · Cleared
ClearedeMurmur ID
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Csd Labs GmbH · DQD Stethoscope, Electronic
Cleared on Apr 17, 2019 as substantially equivalent to K131044 (Diacoustic Medical Devices (Pty), Ltd., 2013) after a 266-day review. Its family tree reaches back 11 generations to 1991. 7 later devices descend from it.
- Decided
- Apr 17, 2019
- Review
- 266 days
- Class
- Class II
- Product code
- DQD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K910772 (1991). 53 ancestors in all, the oldest K771653 (1977). 7 later devices descend from it, 3 citing it directly.
- Root · 11 generations backK910772 Propaq 102, 104 and 106Protocol Systems, Inc. · 1991
- 7 generations between
- 3 generations backK110704 SENSIDiacoustic Medical Devices (Pty), Ltd. · 2011
- 2 generations backK121617 SensicardiacDiacoustic Medical (Pty) · 2012
- 1 generation backK131044 Sensicardiac Mobi Diagnostic Heart Murmur ApplicationDiacoustic Medical Devices (Pty), Ltd. · 2013
- This deviceK181988 eMurmur IDCsd Labs GmbH · 2019
- Descendant · cites it directly · 3 of its ownK213794 Eko Murmur Analysis Software (EMAS)Eko Devices, Inc. · 2022
- Descendant · 2 generations on · 1 of its ownK240901 StethophoneSparrow Acoustics, Inc. · 2024
- Descendant · cites it directly · 1 of its ownK220766 eMurmur Heart AICsd Labs GmbH · 2022
- Descendant · 2 generations on · 0 of its ownK252284 eMurmur Heart AICsd Labs · 2025
- Descendant · 3 generations on · 0 of its ownK252595 Stethophone ProSparrow Acoustics, Inc. · 2025
Show all 11 generations
- Root · 11 generations backK910772 Propaq 102, 104 and 106Protocol Systems, Inc. · 1991
- 10 generations backK972020 Oscillomate Non-Invasive Blood Pressure MonitorCas Medical Systems, Inc. · 1998
- 9 generations backK980879 Oscillomate Nibp / SP02 Ems MonitorCas Medical Systems, Inc. · 1998
- 8 generations backK982776 9303 Neonatal/Adult Vital Signs MonitorCas Medical Systems, Inc. · 1998
- 7 generations backK013319 Nonin Model 2120 Pulse Oximeter and Noninvasive Blood Pressure…Nonin Medical, Inc. · 2002
- 6 generations backK041156 Avant Digital Pulse Oximetry System, Models 4000, 4001Nonin Medical, Inc. · 2004 · Recalled
- 5 generations backK043359 4100 Patient Oximeter ModuleNonin Medical, Inc. · 2005
- 4 generations backK083309 Zargis Acoustic Cardioscan, Version 9.33Zargis Medical Corp. · 2009
- 3 generations backK110704 SENSIDiacoustic Medical Devices (Pty), Ltd. · 2011
- 2 generations backK121617 SensicardiacDiacoustic Medical (Pty) · 2012
- 1 generation backK131044 Sensicardiac Mobi Diagnostic Heart Murmur ApplicationDiacoustic Medical Devices (Pty), Ltd. · 2013
- This deviceK181988 eMurmur IDCsd Labs GmbH · 2019
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K213794Eko Murmur Analysis Software (EMAS)Eko Devices, Inc. · 2022 · cites it directly3descendants
- K240901StethophoneSparrow Acoustics, Inc. · 2024 · 2 generations on1descendant
- K220766eMurmur Heart AICsd Labs GmbH · 2022 · cites it directly1descendant
- K252284eMurmur Heart AICsd Labs · 2025 · 2 generations on0descendants
- K252595Stethophone ProSparrow Acoustics, Inc. · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K910772 | Propaq 102, 104 and 106 | Protocol Systems, Inc. | 1991 | — |
| −10 | K972020 | Oscillomate Non-Invasive Blood Pressure Monitor | Cas Medical Systems, Inc. | 1998 | — |
| −9 | K980879 | Oscillomate Nibp / SP02 Ems Monitor | Cas Medical Systems, Inc. | 1998 | — |
| −8 | K982776 | 9303 Neonatal/Adult Vital Signs Monitor | Cas Medical Systems, Inc. | 1998 | — |
| −7 | K013319 | Nonin Model 2120 Pulse Oximeter and Noninvasive Blood Pressure (Nibp) Monitor | Nonin Medical, Inc. | 2002 | — |
| −6 | K041156 | Avant Digital Pulse Oximetry System, Models 4000, 4001 | Nonin Medical, Inc. | 2004 | 1 |
| −5 | K043359 | 4100 Patient Oximeter Module | Nonin Medical, Inc. | 2005 | — |
| −4 | K083309 | Zargis Acoustic Cardioscan, Version 9.33 | Zargis Medical Corp. | 2009 | — |
| −3 | K110704 | SENSI | Diacoustic Medical Devices (Pty), Ltd. | 2011 | — |
| −2 | K121617 | Sensicardiac | Diacoustic Medical (Pty) | 2012 | — |
| −1 | K131044 | Sensicardiac Mobi Diagnostic Heart Murmur Application | Diacoustic Medical Devices (Pty), Ltd. | 2013 | — |
| 0 (this device) | K181988 | eMurmur ID | Csd Labs GmbH | 2019 | — |
| +1 | K213794 | Eko Murmur Analysis Software (EMAS) | Eko Devices, Inc. | 2022 | — |
| +2 | K240901 | Stethophone | Sparrow Acoustics, Inc. | 2024 | — |
| +1 | K220766 | eMurmur Heart AI | Csd Labs GmbH | 2022 | — |
| +2 | K252284 | eMurmur Heart AI | Csd Labs | 2025 | — |
| +3 | 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 |
| 1990 | 1 | 0 |
| 1992 | 3 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 7 | 0 |
| 1997 | 3 | 0 |
| 1998 | 4 | 0 |
| 1999 | 3 | 0 |
| 2000 | 2 | 0 |
| 2001 | 3 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 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 |
|---|---|---|---|
| * | K131044 | Sensicardiac Mobi Diagnostic Heart Murmur ApplicationSummary page 4…Cardiology PREDICATE DEVICE Company Product 510(k) Diacoustic Medical Devices SensiCardiac Mobi K131044 (Primary Predicate) Discoustic Medical Devices SensiCardiac K121617 (Reference Device) NDICATIONS FOR USE… | 2013 |
| † | K121617 | Sensicardiac | 2012 |
What descends from it? (7)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 28 years and passes through 7 companies; a new generation was cleared every 2.4 years on median.
- 2 of the 53 ancestors have a recall of any class.
- Of its descendants, K213794 (Eko Devices, Inc., 2022) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K131044.
How does its category compare?
All DQD devicesDQD Stethoscope, Electronic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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?
The eMurmur ID software system is a decision support device for the healthcare provider (the user) in the evaluation of patient heart sounds. eMurmur ID is used to record, display, analyze, and store the acoustic signal of the heart, recorded by means of an electronic stethoscope. The automated analysis will identify specific heart sounds that may be present, including S1, S2, physiological heart murmurs, pathological heart murmurs and absence of a heart…
Read the full statement (128 words)
The eMurmur ID software system is a decision support device for the healthcare provider (the user) in the evaluation of patient heart sounds. eMurmur ID is used to record, display, analyze, and store the acoustic signal of the heart, recorded by means of an electronic stethoscope. The automated analysis will identify specific heart sounds that may be present, including S1, S2, physiological heart murmurs, pathological heart murmurs and absence of a heart murmur.
eMurmur ID is indicated for use in a setting where auscultation would typically be performed by a healthcare provider. It is not intended as a sole means of diagnosis. The heart sound interpretations offered by eMurmur ID are only significant when considered in conjunction with healthcare provider over-read and including all other relevant patient data.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181988 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181988: eMurmur ID.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181988
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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