510(k) · Cleared
ClearedSENSI
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 Jun 24, 2011 as substantially equivalent to K083309 (Zargis Medical Corp., 2009) and 1 other predicate after a 102-day review. Its family tree reaches back 8 generations to 1991. 13 later devices descend from it.
- Decided
- Jun 24, 2011
- Review
- 102 days
- Class
- Class II
- Product code
- DQD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K910772 (1991). 49 ancestors in all, the oldest K771653 (1977). 13 later devices descend from it, 2 citing it directly.
- Root · 8 generations backK910772 Propaq 102, 104 and 106Protocol Systems, Inc. · 1991
- 7 generations backK972020 Oscillomate Non-Invasive Blood Pressure MonitorCas Medical Systems, Inc. · 1998
- 6 generations backK980879 Oscillomate Nibp / SP02 Ems MonitorCas Medical Systems, Inc. · 1998
- 5 generations backK982776 9303 Neonatal/Adult Vital Signs MonitorCas Medical Systems, Inc. · 1998
- 4 generations backK013319 Nonin Model 2120 Pulse Oximeter and Noninvasive Blood Pressure…Nonin Medical, Inc. · 2002
- 3 generations backK041156 Avant Digital Pulse Oximetry System, Models 4000, 4001Nonin Medical, Inc. · 2004 · Recalled
- 2 generations backK043359 4100 Patient Oximeter ModuleNonin Medical, Inc. · 2005
- 1 generation backK083309 Zargis Acoustic Cardioscan, Version 9.33Zargis Medical Corp. · 2009
- This deviceK110704 SENSIDiacoustic Medical Devices (Pty), Ltd. · 2011
- Descendant · cites it directly · 10 of its ownK121617 SensicardiacDiacoustic Medical (Pty) · 2012
- Descendant · 2 generations on · 9 of its ownK131044 Sensicardiac Mobi Diagnostic Heart Murmur ApplicationDiacoustic Medical Devices (Pty), Ltd. · 2013
- Descendant · 3 generations on · 7 of its ownK181988 eMurmur IDCsd Labs GmbH · 2019
- Descendant · 3 generations on · 4 of its ownK192004 Eko Analysis SoftwareEko Devices, Inc. · 2020
- Descendant · 4 generations on · 3 of its ownK213794 Eko Murmur Analysis Software (EMAS)Eko Devices, Inc. · 2022
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K121617SensicardiacDiacoustic Medical (Pty) · 2012 · cites it directly10descendants
- K131044Sensicardiac Mobi Diagnostic Heart Murmur ApplicationDiacoustic Medical Devices (Pty), Ltd. · 2013 · 2 generations on9descendants
- K181988eMurmur IDCsd Labs GmbH · 2019 · 3 generations on7descendants
- K192004Eko Analysis SoftwareEko Devices, Inc. · 2020 · 3 generations on4descendants
- K213794Eko Murmur Analysis Software (EMAS)Eko Devices, Inc. · 2022 · 4 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K910772 | Propaq 102, 104 and 106 | Protocol Systems, Inc. | 1991 | — |
| −7 | K972020 | Oscillomate Non-Invasive Blood Pressure Monitor | Cas Medical Systems, Inc. | 1998 | — |
| −6 | K980879 | Oscillomate Nibp / SP02 Ems Monitor | Cas Medical Systems, Inc. | 1998 | — |
| −5 | K982776 | 9303 Neonatal/Adult Vital Signs Monitor | Cas Medical Systems, Inc. | 1998 | — |
| −4 | K013319 | Nonin Model 2120 Pulse Oximeter and Noninvasive Blood Pressure (Nibp) Monitor | Nonin Medical, Inc. | 2002 | — |
| −3 | K041156 | Avant Digital Pulse Oximetry System, Models 4000, 4001 | Nonin Medical, Inc. | 2004 | 1 |
| −2 | K043359 | 4100 Patient Oximeter Module | Nonin Medical, Inc. | 2005 | — |
| −1 | K083309 | Zargis Acoustic Cardioscan, Version 9.33 | Zargis Medical Corp. | 2009 | — |
| 0 (this device) | K110704 | SENSI | Diacoustic Medical Devices (Pty), Ltd. | 2011 | — |
| +1 | K121617 | Sensicardiac | Diacoustic Medical (Pty) | 2012 | — |
| +2 | K131044 | Sensicardiac Mobi Diagnostic Heart Murmur Application | Diacoustic Medical Devices (Pty), Ltd. | 2013 | — |
| +3 | K181988 | eMurmur ID | Csd Labs GmbH | 2019 | — |
| +3 | K192004 | Eko Analysis Software | Eko Devices, Inc. | 2020 | — |
| +4 | K213794 | Eko Murmur Analysis Software (EMAS) | Eko Devices, Inc. | 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 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 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? (2)
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…DQD, DQC Device Class: Class Il PREDICATE DEVICE 807.92(a)(3) Legally Marketed Equivalent Device Company Product 310(k) # Zargis Medical Corp Zargis Acoustic Cardioscan K083309 Meditron AS Meditron II Thestethoscope System K013725 DEVICE DESCRIPTION 807.92(a)(4) The Sensi with Diagnostic Heart Murmur Sof… | 2009 |
| * | K013725 | Meditron II Thesterthoscope SystemSummary page 1…92(a)(3) Legally Marketed Equivalent Device Company Product 310(k) # Zargis Medical Corp Zargis Acoustic Cardioscan K083309 Meditron AS Meditron II Thestethoscope System K013725 DEVICE DESCRIPTION 807.92(a)(4) The Sensi with Diagnostic Heart Murmur Software is a decision support device intended to acquire… | 2002 |
What descends from it? (13)
See all 132 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 20 years and passes through 5 companies; a new generation was cleared every 2.4 years on median.
- 2 of the 49 ancestors have a recall of any class.
- Of its descendants, K121617 (Diacoustic Medical (Pty), 2012) has gone furthest, with 10 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. 2011, 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 Sensi device consisting of the Sensi Diagnostic Heart Murmur Software, the WelchAllyn Master Elite Stethoscope and WelchAllyn USB Analyzer is a decision support device intended to be used on a single patient to assist the medical examiner in analyzing cardiac sounds for the identification and classification of suspected murmurs. It is used to distinguish between normal/physiological and pathological heart murmurs by recording the acoustic signal of…
Read the full statement (242 words)
The Sensi device consisting of the Sensi Diagnostic Heart Murmur Software, the WelchAllyn Master Elite Stethoscope and WelchAllyn USB Analyzer is a decision support device intended to be used on a single patient to assist the medical examiner in analyzing cardiac sounds for the identification and classification of suspected murmurs. It is used to distinguish between normal/physiological and pathological heart murmurs by recording the acoustic signal of the heart and the ECG signal simultaneously and analyze these signals. The acoustic heart signal is analyzed to identify specific heart sounds that may be present. Identified sounds include S1, S2, and suspected systolic murmurs.
Sensi indicates whether or not a recorded heart sound contains a suspected heart murmur and the confidence with which the analysis was made The device must be used in a clinical setting by trained personnel with the prescribed accessories and all relevant patient information must be taken into consideration before a diagnosis is made.
The interpretations of heart sounds offered by the Sensi device are only significant when used in conjunction with physician over-read as well as consideration of all other relevant patient data.
Sensi is not intended to be a diagnostic device. It does not supersede the judgment of the qualified medical personnel. The device is intended to aid the physician in the evaluation of heart sounds. The physicians responsible for reviewing and interpreting the results, along with the auscultatory findings and medical history, in making a referral decision.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K110704 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110704: SENSI.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110704
Report an extraction error
Are you the manufacturer?
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