510(k) · Cleared
ClearedSensicardiac
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diacoustic Medical (Pty) · DQD Stethoscope, Electronic
Cleared on Jul 27, 2012 as substantially equivalent to K083309 (Zargis Medical Corp., 2009) and 2 other predicates after a 56-day review. Its family tree reaches back 9 generations to 1991. 10 later devices descend from it.
- Decided
- Jul 27, 2012
- Review
- 56 days
- Class
- Class II
- Product code
- DQD
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 9 generations to K910772 (1991). 51 ancestors in all, the oldest K771653 (1977). 10 later devices descend from it, 1 citing it directly.
- Root · 9 generations backK910772 Propaq 102, 104 and 106Protocol Systems, Inc. · 1991
- 5 generations between
- 3 generations backK043359 4100 Patient Oximeter ModuleNonin Medical, Inc. · 2005
- 2 generations backK083309 Zargis Acoustic Cardioscan, Version 9.33Zargis Medical Corp. · 2009
- 1 generation backK110704 SENSIDiacoustic Medical Devices (Pty), Ltd. · 2011
- This deviceK121617 SensicardiacDiacoustic Medical (Pty) · 2012
- Descendant · cites it directly · 9 of its ownK131044 Sensicardiac Mobi Diagnostic Heart Murmur ApplicationDiacoustic Medical Devices (Pty), Ltd. · 2013
- Descendant · 2 generations on · 7 of its ownK181988 eMurmur IDCsd Labs GmbH · 2019
- Descendant · 2 generations on · 4 of its ownK192004 Eko Analysis SoftwareEko Devices, Inc. · 2020
- Descendant · 3 generations on · 3 of its ownK213794 Eko Murmur Analysis Software (EMAS)Eko Devices, Inc. · 2022
- Descendant · 4 generations on · 1 of its ownK240901 StethophoneSparrow Acoustics, Inc. · 2024
Show all 9 generations
- Root · 9 generations backK910772 Propaq 102, 104 and 106Protocol Systems, Inc. · 1991
- 8 generations backK972020 Oscillomate Non-Invasive Blood Pressure MonitorCas Medical Systems, Inc. · 1998
- 7 generations backK980879 Oscillomate Nibp / SP02 Ems MonitorCas Medical Systems, Inc. · 1998
- 6 generations backK982776 9303 Neonatal/Adult Vital Signs MonitorCas Medical Systems, Inc. · 1998
- 5 generations backK013319 Nonin Model 2120 Pulse Oximeter and Noninvasive Blood Pressure…Nonin Medical, Inc. · 2002
- 4 generations backK041156 Avant Digital Pulse Oximetry System, Models 4000, 4001Nonin Medical, Inc. · 2004 · Recalled
- 3 generations backK043359 4100 Patient Oximeter ModuleNonin Medical, Inc. · 2005
- 2 generations backK083309 Zargis Acoustic Cardioscan, Version 9.33Zargis Medical Corp. · 2009
- 1 generation backK110704 SENSIDiacoustic Medical Devices (Pty), Ltd. · 2011
- This deviceK121617 SensicardiacDiacoustic Medical (Pty) · 2012
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K131044Sensicardiac Mobi Diagnostic Heart Murmur ApplicationDiacoustic Medical Devices (Pty), Ltd. · 2013 · cites it directly9descendants
- K181988eMurmur IDCsd Labs GmbH · 2019 · 2 generations on7descendants
- K192004Eko Analysis SoftwareEko Devices, Inc. · 2020 · 2 generations on4descendants
- K213794Eko Murmur Analysis Software (EMAS)Eko Devices, Inc. · 2022 · 3 generations on3descendants
- K240901StethophoneSparrow Acoustics, Inc. · 2024 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K910772 | Propaq 102, 104 and 106 | Protocol Systems, Inc. | 1991 | — |
| −8 | K972020 | Oscillomate Non-Invasive Blood Pressure Monitor | Cas Medical Systems, Inc. | 1998 | — |
| −7 | K980879 | Oscillomate Nibp / SP02 Ems Monitor | Cas Medical Systems, Inc. | 1998 | — |
| −6 | K982776 | 9303 Neonatal/Adult Vital Signs Monitor | Cas Medical Systems, Inc. | 1998 | — |
| −5 | K013319 | Nonin Model 2120 Pulse Oximeter and Noninvasive Blood Pressure (Nibp) Monitor | Nonin Medical, Inc. | 2002 | — |
| −4 | K041156 | Avant Digital Pulse Oximetry System, Models 4000, 4001 | Nonin Medical, Inc. | 2004 | 1 |
| −3 | K043359 | 4100 Patient Oximeter Module | Nonin Medical, Inc. | 2005 | — |
| −2 | K083309 | Zargis Acoustic Cardioscan, Version 9.33 | Zargis Medical Corp. | 2009 | — |
| −1 | K110704 | SENSI | Diacoustic Medical Devices (Pty), Ltd. | 2011 | — |
| 0 (this device) | K121617 | Sensicardiac | Diacoustic Medical (Pty) | 2012 | — |
| +1 | K131044 | Sensicardiac Mobi Diagnostic Heart Murmur Application | Diacoustic Medical Devices (Pty), Ltd. | 2013 | — |
| +2 | K181988 | eMurmur ID | Csd Labs GmbH | 2019 | — |
| +2 | K192004 | Eko Analysis Software | Eko Devices, Inc. | 2020 | — |
| +3 | K213794 | Eko Murmur Analysis Software (EMAS) | Eko Devices, Inc. | 2022 | — |
| +4 | K240901 | Stethophone | Sparrow Acoustics, Inc. | 2024 | — |
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 |
|---|---|---|
| 2013 | 1 | 0 |
| 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? (3)
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 |
|---|---|---|---|
| * | K083309 | Zargis Acoustic Cardioscan, Version 9.33Summary page 1…ent Device Company Product 5 10(k) Zargis Medical Corp Zargis Acoustic Cardioscan K083309 Stethographics Inc. Stethographics Heart STG K052283 S… | 2009 |
| * | K052283 | Heart STG System and SoftwareSummary page 1…5 10(k) Zargis Medical Corp Zargis Acoustic Cardioscan K083309 Stethographics Inc. Stethographics Heart STG K052283 System Diacoustic Medical Devices Sensi Cardiac Diagnostic K1… | 2005 |
| * | K110704 | SENSISummary page 1…hographics Heart STG K052283 System Diacoustic Medical Devices Sensi Cardiac Diagnostic K110704 Heart Murmur Software DEVICE DESCRIPTION… | 2011 |
What descends from it? (10)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K131044 | Sensicardiac Mobi Diagnostic Heart Murmur Application | 2013 | 9 |
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 21 years and passes through 6 companies; a new generation was cleared every 2.4 years on median.
- 2 of the 51 ancestors have a recall of any class.
- Of its descendants, K131044 (Diacoustic Medical Devices (Pty), Ltd., 2013) has gone furthest, with 9 descendants of its own.
- 1 other device also cites its predicate K083309.
How does its category compare?
All DQD devicesDQD Stethoscope, Electronic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 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 (122 words)
The SensiCardiac 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 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/K121617 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121617: Sensicardiac.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121617
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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