510(k) · Cleared
ClearedZargis Acoustic Cardioscan, Version 9.33
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zargis Medical Corp. · DQD Stethoscope, Electronic
Cleared on Feb 13, 2009 as substantially equivalent to K031517 (Zargis Medical Corp., 2004) and 5 other predicates after a 95-day review. Its family tree reaches back 7 generations to 1991. 14 later devices descend from it.
- Decided
- Feb 13, 2009
- Review
- 95 days
- Class
- Class II
- Product code
- DQD
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 7 generations to K910772 (1991). 38 ancestors in all, the oldest K863116 (1986). 14 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK910772 Propaq 102, 104 and 106Protocol Systems, Inc. · 1991
- 6 generations backK972020 Oscillomate Non-Invasive Blood Pressure MonitorCas Medical Systems, Inc. · 1998
- 5 generations backK980879 Oscillomate Nibp / SP02 Ems MonitorCas Medical Systems, Inc. · 1998
- 4 generations backK982776 9303 Neonatal/Adult Vital Signs MonitorCas Medical Systems, Inc. · 1998
- 3 generations backK013319 Nonin Model 2120 Pulse Oximeter and Noninvasive Blood Pressure…Nonin Medical, Inc. · 2002
- 2 generations backK041156 Avant Digital Pulse Oximetry System, Models 4000, 4001Nonin Medical, Inc. · 2004 · Recalled
- 1 generation backK043359 4100 Patient Oximeter ModuleNonin Medical, Inc. · 2005
- This deviceK083309 Zargis Acoustic Cardioscan, Version 9.33Zargis Medical Corp. · 2009
- Descendant · cites it directly · 13 of its ownK110704 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
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K110704SENSIDiacoustic Medical Devices (Pty), Ltd. · 2011 · cites it directly13descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K910772 | Propaq 102, 104 and 106 | Protocol Systems, Inc. | 1991 | — |
| −6 | K972020 | Oscillomate Non-Invasive Blood Pressure Monitor | Cas Medical Systems, Inc. | 1998 | — |
| −5 | K980879 | Oscillomate Nibp / SP02 Ems Monitor | Cas Medical Systems, Inc. | 1998 | — |
| −4 | K982776 | 9303 Neonatal/Adult Vital Signs Monitor | Cas Medical Systems, Inc. | 1998 | — |
| −3 | K013319 | Nonin Model 2120 Pulse Oximeter and Noninvasive Blood Pressure (Nibp) Monitor | Nonin Medical, Inc. | 2002 | — |
| −2 | K041156 | Avant Digital Pulse Oximetry System, Models 4000, 4001 | Nonin Medical, Inc. | 2004 | 1 |
| −1 | K043359 | 4100 Patient Oximeter Module | Nonin Medical, Inc. | 2005 | — |
| 0 (this device) | K083309 | Zargis Acoustic Cardioscan, Version 9.33 | Zargis Medical Corp. | 2009 | — |
| +1 | 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 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1990 | 1 | 0 |
| 1992 | 3 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 3 | 0 |
| 1998 | 4 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 3 | 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 |
|---|---|---|
| 2011 | 1 | 0 |
| 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? (6)
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 |
|---|---|---|---|
| * | K031517 | Zargis Acoustic CardioscanSummary page 1…pared By: John Kallassy CEO Date Prepared: November 3, 2008 Predicate Devices: Zargis Acoustic Cardioscan, K031517, K042128, K060197 AViTA Bluetooth Blood Pressure Monitor, K072 137 Card… | 2004 |
| * | K042128 | Modification to Zargis Acoustic Cardioscan (Zac)Summary page 1…John Kallassy CEO Date Prepared: November 3, 2008 Predicate Devices: Zargis Acoustic Cardioscan, K031517, K042128, K060197 AViTA Bluetooth Blood Pressure Monitor, K072 137 CardioBeolfJI… | 2004 |
| * | K060197 | Zargis Acoustic Cardioscan (Zac), Model Zac 6.28Summary page 1…John Kallassy CEO Date Prepared: November 3, 2008 Predicate Devices: Zargis Acoustic Cardioscan, K031517, K042128, K060197 AViTA Bluetooth Blood Pressure Monitor, K072 137 CardioBeolfJIElectrode… | 2006 |
| * | K072137 | Avita Bluetooth Blood Pressure Monitor, Model: BPM656ZBSummary page 1…November 3, 2008 Predicate Devices: Zargis Acoustic Cardioscan, K031517, K042128, K060197 AViTA Bluetooth Blood Pressure Monitor, K072 137 CardioBeolfJIElectrode Belt, K063 044 Nonin Medical, Inc. Model 41 00 P… | 2007 |
| * | K063044 | Cardiobelt Electrode BeltSummary page 1…ioscan, K031517, K042128, K060197 AViTA Bluetooth Blood Pressure Monitor, K072 137 CardioBeolfJIElectrode Belt, K063 044 Nonin Medical, Inc. Model 41 00 Patient Oximeter Module, K043359 Devic… | 2007 |
| * | K043359 | 4100 Patient Oximeter ModuleSummary page 1…CardioBeolfJIElectrode Belt, K063 044 Nonin Medical, Inc. Model 41 00 Patient Oximeter Module, K043359 Device Description: The ZAC isan electronic auscultatory device intended to acquire, record, and analyze heart sounds. The comp… | 2005 |
What descends from it? (14)
See all 142 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 18 years and passes through 4 companies; a new generation was cleared every 2.4 years on median.
- 2 of the 38 ancestors have a recall of any class.
- Of its descendants, K110704 (Diacoustic Medical Devices (Pty), Ltd., 2011) has gone furthest, with 13 descendants of its own.
- 3 other devices also cite its predicate K031517.
How does its category compare?
All DQD devicesDQD Stethoscope, Electronic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 Zargis Acoustic Cardioscan, (ZAC) is an electronic auscultatory device, intended to provide support to the physician in the evaluation of heart sounds in patients. The product will acquire and record the acoustic signals of the heart and analyze 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…
Read the full statement (129 words)
The Zargis Acoustic Cardioscan, (ZAC) is an electronic auscultatory device, intended to provide support to the physician in the evaluation of heart sounds in patients.
The product will acquire and record the acoustic signals of the heart and analyze 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 Zargis Acoustic Cardioscan 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/K083309 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083309: Zargis Acoustic Cardioscan, Version 9.33.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083309
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