510(k) · Cleared
ClearedMeditron Stethoscope 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 Jul 19, 1999 as substantially equivalent to K961301 (Delphi Consulting Group, 1996) and 3 other predicates after a 90-day review. Its family tree reaches back 2 generations to 1977. 51 later devices descend from it.
- Decided
- Jul 19, 1999
- Review
- 90 days
- Class
- Class II
- Product code
- DQD
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K771653 (1977). 5 ancestors in all. 51 later devices descend from it, 6 citing it directly.
- Root · 2 generations backK771653 Electronic Stethoscope3M Company · 1977
- 1 generation backK961857 Labtron Electromax Electronic Stethoscope Model NO. 04-1060Graham-Field, Inc. · 1996
- This deviceK991367 Meditron Stethoscope SystemMeditron AS · 1999
- Descendant · cites it directly · 29 of its ownK072026 RNK Electronic StethoscopeRnk Products, Inc. · 2007
- Descendant · 2 generations on · 26 of its ownK102893 PCP/PC StethoscopeRnk Products, Inc. · 2011
- Descendant · 3 generations on · 21 of its ownK160401 Tyto StethoscopeTyto Care, Ltd. · 2016
- Descendant · 4 generations on · 19 of its ownK181612 Tyto Stethoscope (OTC)Tyto Care, Ltd. · 2018
- Descendant · cites it directly · 16 of its ownK013725 Meditron II Thesterthoscope SystemMeditron AS · 2002
Showing 5 of 51 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 51 · See all- K072026RNK Electronic StethoscopeRnk Products, Inc. · 2007 · cites it directly29descendants
- K102893PCP/PC StethoscopeRnk Products, Inc. · 2011 · 2 generations on26descendants
- K160401Tyto StethoscopeTyto Care, Ltd. · 2016 · 3 generations on21descendants
- K181612Tyto Stethoscope (OTC)Tyto Care, Ltd. · 2018 · 4 generations on19descendants
- K013725Meditron II Thesterthoscope SystemMeditron AS · 2002 · cites it directly16descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K771653 | Electronic Stethoscope | 3M Company | 1977 | — |
| −1 | K961857 | Labtron Electromax Electronic Stethoscope Model NO. 04-1060 | Graham-Field, Inc. | 1996 | — |
| 0 (this device) | K991367 | Meditron Stethoscope System | Meditron AS | 1999 | — |
| +1 | K072026 | RNK Electronic Stethoscope | Rnk Products, Inc. | 2007 | — |
| +2 | K102893 | PCP/PC Stethoscope | Rnk Products, Inc. | 2011 | — |
| +3 | K160401 | Tyto Stethoscope | Tyto Care, Ltd. | 2016 | — |
| +4 | K181612 | Tyto Stethoscope (OTC) | Tyto Care, Ltd. | 2018 | — |
| +1 | K013725 | Meditron II Thesterthoscope System | Meditron AS | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 4 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 3 | 0 |
| 2021 | 3 | 0 |
| 2022 | 6 | 0 |
| 2023 | 7 | 0 |
| 2024 | 2 | 0 |
| 2025 | 4 | 0 |
| 2026 | 4 | 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? (4)
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 |
|---|---|---|---|
| * | K961301 | E-Scope Electronic Stethoscope Model 718-7120Summary page 1…aration: April 12, 1999 Name of Device: Meditron stethoscope system (electronic-amplified stethoscope) Predicate Devices: E-scope Electronic Stethoscope Model 718-7120 (K961301) DELWA-STAR® STETHOS™ (K963621) SimmlScope® Ausculation System (K961937) Labtron Electromax Electronic Stethoscope Model N (K9618… | 1996 |
| * | K963621 | StethosSummary page 1…Device: Meditron stethoscope system (electronic-amplified stethoscope) Predicate Devices: E-scope Electronic Stethoscope Model 718-7120 (K961301) DELWA-STAR® STETHOS™ (K963621) SimmlScope® Ausculation System (K961937) Labtron Electromax Electronic Stethoscope Model N (K961837) Device Description and Int… | 1996 |
| * | K961937 | Simulscope Auscultation and Simulscope Bedside Auscultation SystemSummary page 1…ctronic-amplified stethoscope) Predicate Devices: E-scope Electronic Stethoscope Model 718-7120 (K961301) DELWA-STAR® STETHOS™ (K963621) SimmlScope® Ausculation System (K961937) Labtron Electromax Electronic Stethoscope Model N (K961837) Device Description and Intended Use: The Meditron stethoscope syst… | 1996 |
| * | K961857 | Labtron Electromax Electronic Stethoscope Model NO. 04-1060 Our OCR of the scanned summary read K961837, FDA’s number for Rush Oral/Nasal Tracheal Tube Cuffed Magill/Murphy (Rusch Intl.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Labtron Electromax Electronic Stethoscope Model N”. | 1996 |
What descends from it? (51)
See all 516 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 22 years and passes through 3 companies; a new generation was cleared every 18.8 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K072026 (Rnk Products, Inc., 2007) has gone furthest, with 29 descendants of its own.
- 4 other devices also cite its predicate K961301.
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 Meditron Stethoscope System is intended for use as a diagnostic aid in patient diagnosis, treatment and monitoring. It amplifies sounds from the bodys internal organs, mainly the heart and respitatory and circulatory omgans. It provides computer-aided recordings of these sounds and stores these recordings along with other appropriate 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/K991367 · printed Nov 4, 2026
Cite this page
510(k) Report. “K991367: Meditron Stethoscope System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K991367
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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