510(k) · Cleared
ClearedZargis Acoustic Cardioscan
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 May 26, 2004 as substantially equivalent to K031182 (Mortara Instrument, Inc., 2003) and 1 other predicate after a 377-day review. Its family tree reaches back 4 generations to 1994. 19 later devices descend from it.
- Decided
- May 26, 2004
- Review
- 377 days
- Class
- Class II
- Product code
- DQD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K930806 (1994). 8 ancestors in all, the oldest K920626 (1992). 19 later devices descend from it, 4 citing it directly.
- Root · 4 generations backK930806 Zymed Holter Scanner Model 2010Agilent Technologies · 1994
- 3 generations backK955015 Zymed Holter Scanner Model 2010Zymed Medical Instrumentation · 1996
- 2 generations backK990170 Holter 2000Zymed Medical Instrumentation · 1999
- 1 generation backK010949 2010 Plus Holter for WindowsAgilent Technologies · 2001
- This deviceK031517 Zargis Acoustic CardioscanZargis Medical Corp. · 2004
- Descendant · cites it directly · 15 of its ownK060197 Zargis Acoustic Cardioscan (Zac), Model Zac 6.28Zargis Medical Corp. · 2006
- Descendant · cites it directly · 14 of its ownK083309 Zargis Acoustic Cardioscan, Version 9.33Zargis Medical Corp. · 2009
- Descendant · 2 generations on · 13 of its ownK110704 SENSIDiacoustic Medical Devices (Pty), Ltd. · 2011
- Descendant · cites it directly · 11 of its ownK052283 Heart STG System and SoftwareStethographics, Inc. · 2005
- Descendant · 2 generations on · 10 of its ownK121617 SensicardiacDiacoustic Medical (Pty) · 2012
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K060197Zargis Acoustic Cardioscan (Zac), Model Zac 6.28Zargis Medical Corp. · 2006 · cites it directly15descendants
- K083309Zargis Acoustic Cardioscan, Version 9.33Zargis Medical Corp. · 2009 · cites it directly14descendants
- K110704SENSIDiacoustic Medical Devices (Pty), Ltd. · 2011 · 2 generations on13descendants
- K052283Heart STG System and SoftwareStethographics, Inc. · 2005 · cites it directly11descendants
- K121617SensicardiacDiacoustic Medical (Pty) · 2012 · 2 generations on10descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K930806 | Zymed Holter Scanner Model 2010 | Agilent Technologies | 1994 | — |
| −3 | K955015 | Zymed Holter Scanner Model 2010 | Zymed Medical Instrumentation | 1996 | — |
| −2 | K990170 | Holter 2000 | Zymed Medical Instrumentation | 1999 | — |
| −1 | K010949 | 2010 Plus Holter for Windows | Agilent Technologies | 2001 | — |
| 0 (this device) | K031517 | Zargis Acoustic Cardioscan | Zargis Medical Corp. | 2004 | — |
| +1 | K060197 | Zargis Acoustic Cardioscan (Zac), Model Zac 6.28 | Zargis Medical Corp. | 2006 | — |
| +1 | K083309 | Zargis Acoustic Cardioscan, Version 9.33 | Zargis Medical Corp. | 2009 | — |
| +2 | K110704 | SENSI | Diacoustic Medical Devices (Pty), Ltd. | 2011 | — |
| +1 | K052283 | Heart STG System and Software | Stethographics, Inc. | 2005 | — |
| +2 | K121617 | Sensicardiac | Diacoustic Medical (Pty) | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 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 |
|---|---|---|---|
| * | K031182 | Eli 200+ Audicor Cleared while this submission was under review Summary page 1…Shahram Hejazi, Ph.D. President/CEO Date Prepared: March 26, 2004 Predicate Devices: ELI 200+ Audicor - K031182 2010 Holter Plus Monitor - K010949 Device Description: The ZAC is an electronic auscultatory devi… | 2003 |
| * | K010949 | 2010 Plus Holter for WindowsSummary page 1…ent/CEO Date Prepared: March 26, 2004 Predicate Devices: ELI 200+ Audicor - K031182 2010 Holter Plus Monitor - K010949 Device Description: The ZAC is an electronic auscultatory device intended to acquire, record, and analyze heart sounds. Heart so… | 2001 |
What descends from it? (19)
See all 194 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 10 years and passes through 3 companies; a new generation was cleared every 2.7 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K060197 (Zargis Medical Corp., 2006) has gone furthest, with 15 descendants of its own.
- 4 other devices also cite its predicate K031182.
How does its category compare?
All DQD devicesDQD Stethoscope, Electronic: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 SI, S2, and suspected murmurs. The device is indicated for use in a clinical setting…
Read the full statement (128 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 SI, 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/K031517 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031517: Zargis Acoustic Cardioscan.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031517
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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