510(k) · Cleared
ClearedHeart STG System and Software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stethographics, Inc. · DQD Stethoscope, Electronic
Cleared on Dec 23, 2005 as substantially equivalent to K031517 (Zargis Medical Corp., 2004) after a 123-day review. Its family tree reaches back 5 generations to 1994. 11 later devices descend from it.
- Decided
- Dec 23, 2005
- Review
- 123 days
- Class
- Class II
- Product code
- DQD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K930806 (1994). 9 ancestors in all, the oldest K920626 (1992). 11 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK930806 Zymed Holter Scanner Model 2010Agilent Technologies · 1994
- 4 generations backK955015 Zymed Holter Scanner Model 2010Zymed Medical Instrumentation · 1996
- 3 generations backK990170 Holter 2000Zymed Medical Instrumentation · 1999
- 2 generations backK010949 2010 Plus Holter for WindowsAgilent Technologies · 2001
- 1 generation backK031517 Zargis Acoustic CardioscanZargis Medical Corp. · 2004
- This deviceK052283 Heart STG System and SoftwareStethographics, Inc. · 2005
- 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 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · 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 |
|---|---|---|---|---|---|
| −5 | K930806 | Zymed Holter Scanner Model 2010 | Agilent Technologies | 1994 | — |
| −4 | K955015 | Zymed Holter Scanner Model 2010 | Zymed Medical Instrumentation | 1996 | — |
| −3 | K990170 | Holter 2000 | Zymed Medical Instrumentation | 1999 | — |
| −2 | K010949 | 2010 Plus Holter for Windows | Agilent Technologies | 2001 | — |
| −1 | K031517 | Zargis Acoustic Cardioscan | Zargis Medical Corp. | 2004 | — |
| 0 (this device) | K052283 | Heart STG System and Software | Stethographics, Inc. | 2005 | — |
| +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 |
|---|---|---|
| 1992 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K031517 | Zargis Acoustic CardioscanSummary page 1…n Name: Heart STG System 21 CFR 870.1870 Predicate Devices: The Stethographics Heart STG System is substantially equivalent to the Zargis' Acoustic Cardioscan (#K031517). Stethographics 5 10(k) December 2005 tteart STG… | 2004 |
What descends from it? (11)
See all 111 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K121617 | Sensicardiac | 2012 | 10 |
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 11 years and passes through 4 companies; a new generation was cleared every 2.5 years on median.
- None of the 9 ancestors has a recall.
- Of its descendants, K121617 (Diacoustic Medical (Pty), 2012) has gone furthest, with 10 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.
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 Stethographics Heart STG System, 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 St, S2, and suspected systolic murmurs. The device is indicated for use in the clinical…
Read the full statement (129 words)
The Stethographics Heart STG System, 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 St, S2, and suspected systolic murmurs.
The device is indicated for use in the clinical setting, by a physician or by trained personnel who are acting on the orders of a licensed physician. It in not intended as a sole means of diagnosis.
The interpretations of heart sounds offered by the Heart STG System are only significant when used in conjunction with physician over-read as well as consideration of all relevant patient data.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052283 · printed Nov 4, 2026
Cite this page
510(k) Report. “K052283: Heart STG System and Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K052283
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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