510(k) · Cleared
ClearedSensicardiac Mobi Diagnostic Heart Murmur Application
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diacoustic Medical Devices (Pty), Ltd. · DQD Stethoscope, Electronic
Cleared on Sep 4, 2013 as substantially equivalent to K121617 (Diacoustic Medical (Pty), 2012) after a 142-day review. Its family tree reaches back 10 generations to 1991. 9 later devices descend from it.
- Decided
- Sep 4, 2013
- Review
- 142 days
- Class
- Class II
- Product code
- DQD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K910772 (1991). 52 ancestors in all, the oldest K771653 (1977). 9 later devices descend from it, 2 citing it directly.
- Root · 10 generations backK910772 Propaq 102, 104 and 106Protocol Systems, Inc. · 1991
- 6 generations between
- 3 generations backK083309 Zargis Acoustic Cardioscan, Version 9.33Zargis Medical Corp. · 2009
- 2 generations backK110704 SENSIDiacoustic Medical Devices (Pty), Ltd. · 2011
- 1 generation backK121617 SensicardiacDiacoustic Medical (Pty) · 2012
- This deviceK131044 Sensicardiac Mobi Diagnostic Heart Murmur ApplicationDiacoustic Medical Devices (Pty), Ltd. · 2013
- Descendant · cites it directly · 7 of its ownK181988 eMurmur IDCsd Labs GmbH · 2019
- Descendant · cites it directly · 4 of its ownK192004 Eko Analysis SoftwareEko Devices, Inc. · 2020
- Descendant · 2 generations on · 3 of its ownK213794 Eko Murmur Analysis Software (EMAS)Eko Devices, Inc. · 2022
- Descendant · 3 generations on · 1 of its ownK240901 StethophoneSparrow Acoustics, Inc. · 2024
- Descendant · 2 generations on · 1 of its ownK220766 eMurmur Heart AICsd Labs GmbH · 2022
Show all 10 generations
- Root · 10 generations backK910772 Propaq 102, 104 and 106Protocol Systems, Inc. · 1991
- 9 generations backK972020 Oscillomate Non-Invasive Blood Pressure MonitorCas Medical Systems, Inc. · 1998
- 8 generations backK980879 Oscillomate Nibp / SP02 Ems MonitorCas Medical Systems, Inc. · 1998
- 7 generations backK982776 9303 Neonatal/Adult Vital Signs MonitorCas Medical Systems, Inc. · 1998
- 6 generations backK013319 Nonin Model 2120 Pulse Oximeter and Noninvasive Blood Pressure…Nonin Medical, Inc. · 2002
- 5 generations backK041156 Avant Digital Pulse Oximetry System, Models 4000, 4001Nonin Medical, Inc. · 2004 · Recalled
- 4 generations backK043359 4100 Patient Oximeter ModuleNonin Medical, Inc. · 2005
- 3 generations backK083309 Zargis Acoustic Cardioscan, Version 9.33Zargis Medical Corp. · 2009
- 2 generations backK110704 SENSIDiacoustic Medical Devices (Pty), Ltd. · 2011
- 1 generation backK121617 SensicardiacDiacoustic Medical (Pty) · 2012
- This deviceK131044 Sensicardiac Mobi Diagnostic Heart Murmur ApplicationDiacoustic Medical Devices (Pty), Ltd. · 2013
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K181988eMurmur IDCsd Labs GmbH · 2019 · cites it directly7descendants
- K192004Eko Analysis SoftwareEko Devices, Inc. · 2020 · cites it directly4descendants
- K213794Eko Murmur Analysis Software (EMAS)Eko Devices, Inc. · 2022 · 2 generations on3descendants
- K240901StethophoneSparrow Acoustics, Inc. · 2024 · 3 generations on1descendant
- K220766eMurmur Heart AICsd Labs GmbH · 2022 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K910772 | Propaq 102, 104 and 106 | Protocol Systems, Inc. | 1991 | — |
| −9 | K972020 | Oscillomate Non-Invasive Blood Pressure Monitor | Cas Medical Systems, Inc. | 1998 | — |
| −8 | K980879 | Oscillomate Nibp / SP02 Ems Monitor | Cas Medical Systems, Inc. | 1998 | — |
| −7 | K982776 | 9303 Neonatal/Adult Vital Signs Monitor | Cas Medical Systems, Inc. | 1998 | — |
| −6 | K013319 | Nonin Model 2120 Pulse Oximeter and Noninvasive Blood Pressure (Nibp) Monitor | Nonin Medical, Inc. | 2002 | — |
| −5 | K041156 | Avant Digital Pulse Oximetry System, Models 4000, 4001 | Nonin Medical, Inc. | 2004 | 1 |
| −4 | K043359 | 4100 Patient Oximeter Module | Nonin Medical, Inc. | 2005 | — |
| −3 | K083309 | Zargis Acoustic Cardioscan, Version 9.33 | Zargis Medical Corp. | 2009 | — |
| −2 | K110704 | SENSI | Diacoustic Medical Devices (Pty), Ltd. | 2011 | — |
| −1 | K121617 | Sensicardiac | Diacoustic Medical (Pty) | 2012 | — |
| 0 (this device) | K131044 | Sensicardiac Mobi Diagnostic Heart Murmur Application | Diacoustic Medical Devices (Pty), Ltd. | 2013 | — |
| +1 | K181988 | eMurmur ID | Csd Labs GmbH | 2019 | — |
| +1 | K192004 | Eko Analysis Software | Eko Devices, Inc. | 2020 | — |
| +2 | K213794 | Eko Murmur Analysis Software (EMAS) | Eko Devices, Inc. | 2022 | — |
| +3 | K240901 | Stethophone | Sparrow Acoustics, Inc. | 2024 | — |
| +2 | K220766 | eMurmur Heart AI | Csd Labs GmbH | 2022 | — |
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 |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K121617 | SensicardiacSummary page 1…ivalent Device Company Product 5 10(k) Diacoustic Medical Devices Sensi Cardiac Diagnostic K1 21617 Heart Murmur Software DEVICE DESCRIPTION… | 2012 |
What descends from it? (9)
2 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 22 years and passes through 6 companies; a new generation was cleared every 2.4 years on median.
- 2 of the 52 ancestors have a recall of any class.
- Of its descendants, K181988 (Csd Labs GmbH, 2019) has gone furthest, with 7 descendants of its own.
How does its category compare?
All DQD devicesDQD Stethoscope, Electronic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 SensiCardiac Mobi is an electronic auscultatory device, intended to provide support to the physician in the evaluation of patients' heart sounds. The product acquires and records the acoustic signals of the heart and analyzes these signals. The analysis procedure will identify specific heart sounds that may be present. Identified sounds include S1, S2, and suspected murmurs. The device is indicated for use in a clinical setting, by a physician or by…
Read the full statement (124 words)
The SensiCardiac Mobi is an electronic auscultatory device, intended to provide support to the physician in the evaluation of patients' heart sounds.
The product acquires and records the acoustic signals of the heart and analyzes these signals. The analysis procedure will identify specific heart sounds that may be present. Identified sounds include S1, S2, and suspected murmurs. The device is indicated for use in a clinical setting, by a physician or by trained personnel who are acting on the orders of a licensed physician. It is not intended as a sole means of diagnosis.
The interpretations of heart sounds offered by the SensiCardiac Mobi are only significant when used in conjunction with physician over-read as well as consideration of all other relevant patient data.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131044 · printed Nov 5, 2026
Cite this page
510(k) Report. “K131044: Sensicardiac Mobi Diagnostic Heart Murmur Application.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K131044
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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