510(k) · Cleared
ClearedMeditron II Thesterthoscope System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Meditron AS · DQD Stethoscope, Electronic
Cleared on Jan 30, 2002 as substantially equivalent to K990809 (Caditec AG, 1999) and 2 other predicates after an 82-day review. Its family tree reaches back 3 generations to 1977. 16 later devices descend from it.
- Decided
- Jan 30, 2002
- Review
- 82 days
- Class
- Class II
- Product code
- DQD
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K771653 (1977). 9 ancestors in all. 16 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK771653 Electronic Stethoscope3M Company · 1977
- 2 generations backK961857 Labtron Electromax Electronic Stethoscope Model NO. 04-1060Graham-Field, Inc. · 1996
- 1 generation backK991367 Meditron Stethoscope SystemMeditron AS · 1999
- This deviceK013725 Meditron II Thesterthoscope SystemMeditron AS · 2002
- Descendant · cites it directly · 13 of its ownK110704 SENSIDiacoustic Medical Devices (Pty), Ltd. · 2011
- Descendant · 2 generations on · 10 of its ownK121617 SensicardiacDiacoustic Medical (Pty) · 2012
- Descendant · 3 generations on · 9 of its ownK131044 Sensicardiac Mobi Diagnostic Heart Murmur ApplicationDiacoustic Medical Devices (Pty), Ltd. · 2013
- Descendant · 4 generations on · 7 of its ownK181988 eMurmur IDCsd Labs GmbH · 2019
- Descendant · 4 generations on · 4 of its ownK192004 Eko Analysis SoftwareEko Devices, Inc. · 2020
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K110704SENSIDiacoustic Medical Devices (Pty), Ltd. · 2011 · cites it directly13descendants
- K121617SensicardiacDiacoustic Medical (Pty) · 2012 · 2 generations on10descendants
- K131044Sensicardiac Mobi Diagnostic Heart Murmur ApplicationDiacoustic Medical Devices (Pty), Ltd. · 2013 · 3 generations on9descendants
- K181988eMurmur IDCsd Labs GmbH · 2019 · 4 generations on7descendants
- K192004Eko Analysis SoftwareEko Devices, Inc. · 2020 · 4 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K771653 | Electronic Stethoscope | 3M Company | 1977 | — |
| −2 | K961857 | Labtron Electromax Electronic Stethoscope Model NO. 04-1060 | Graham-Field, Inc. | 1996 | — |
| −1 | K991367 | Meditron Stethoscope System | Meditron AS | 1999 | — |
| 0 (this device) | K013725 | Meditron II Thesterthoscope System | Meditron AS | 2002 | — |
| +1 | K110704 | SENSI | Diacoustic Medical Devices (Pty), Ltd. | 2011 | — |
| +2 | K121617 | Sensicardiac | Diacoustic Medical (Pty) | 2012 | — |
| +3 | K131044 | Sensicardiac Mobi Diagnostic Heart Murmur Application | Diacoustic Medical Devices (Pty), Ltd. | 2013 | — |
| +4 | K181988 | eMurmur ID | Csd Labs GmbH | 2019 | — |
| +4 | K192004 | Eko Analysis Software | Eko Devices, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1996 | 4 | 0 |
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K990809 | Cadiscope Electronic StethoscopeSummary page 1…te Summary Prepared: November 7, 2001 Device Name: Meditron II thestethoscope system Predicate Devices: CADItec AG CADIscope Electronic Stethoscope with Integrated ECG (K990809) Meditron thestethoscope system (K991367) Kendall-LTP Disposable ECG Electrode (K953649) Device Description and Intended Use: T… | 1999 |
| * | K991367 | Meditron Stethoscope SystemSummary page 1…ice Name: Meditron II thestethoscope system Predicate Devices: CADItec AG CADIscope Electronic Stethoscope with Integrated ECG (K990809) Meditron thestethoscope system (K991367) Kendall-LTP Disposable ECG Electrode (K953649) Device Description and Intended Use: The Meditron electronic stethoscope system… | 1999 |
| * | K953649 | Disposable Ecg ElectrodeSummary page 1…edicate Devices: CADItec AG CADIscope Electronic Stethoscope with Integrated ECG (K990809) Meditron thestethoscope system (K991367) Kendall-LTP Disposable ECG Electrode (K953649) Device Description and Intended Use: The Meditron electronic stethoscope system is intended for use as a diagnostic aid in pat… | 1996 |
What descends from it? (16)
See all 162 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 25 years and passes through 3 companies; a new generation was cleared every 3.0 years on median.
- None of the 9 ancestors has a recall.
- Of its descendants, K110704 (Diacoustic Medical Devices (Pty), Ltd., 2011) has gone furthest, with 13 descendants of its own.
- 5 other devices also cite its predicate K990809.
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?
Intended for use as a diagnostic aid in patient diagnosis, treatment, and monitoring. It amplifies sounds from the body’s internal organs, mainly the heart and circulatory and respiratory organs. The system is includes a 3-lead electrocardiograph that produces a visual display of the electrocardiogram (ECG) on the PC monitor to enable the healthcare practitioner to synchronize the phonocardiogram with the beginning of the heart cycle. The ECG is nnot intended for diagnostic use. The system provides computer-aided recordings and storage of these sounds along with other patient information.
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/K013725 · printed Nov 5, 2026
Cite this page
510(k) Report. “K013725: Meditron II Thesterthoscope System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K013725
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026