510(k) · Cleared
ClearedSimulscope Auscultation and Simulscope Bedside Auscultation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Delphi Consulting Group · DQD Stethoscope, Electronic
Cleared on Dec 9, 1996 after a 203-day review. The FDA summary names its predicate without a number. 52 later devices descend from it.
- Decided
- Dec 9, 1996
- Review
- 203 days
- Class
- Class II
- Product code
- DQD
- Recalls
- None
- Predicates
- 0
52 later devices descend from it, 1 citing it directly.
- This deviceK961937 Simulscope Auscultation and Simulscope Bedside Auscultation SystemDelphi Consulting Group · 1996
- Descendant · cites it directly · 51 of its ownK991367 Meditron Stethoscope SystemMeditron AS · 1999
- Descendant · 2 generations on · 29 of its ownK072026 RNK Electronic StethoscopeRnk Products, Inc. · 2007
- Descendant · 3 generations on · 26 of its ownK102893 PCP/PC StethoscopeRnk Products, Inc. · 2011
- Descendant · 4 generations on · 21 of its ownK160401 Tyto StethoscopeTyto Care, Ltd. · 2016
- Descendant · 5 generations on · 19 of its ownK181612 Tyto Stethoscope (OTC)Tyto Care, Ltd. · 2018
Showing 5 of 52 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 52 · See all- K991367Meditron Stethoscope SystemMeditron AS · 1999 · cites it directly51descendants
- K072026RNK Electronic StethoscopeRnk Products, Inc. · 2007 · 2 generations on29descendants
- K102893PCP/PC StethoscopeRnk Products, Inc. · 2011 · 3 generations on26descendants
- K160401Tyto StethoscopeTyto Care, Ltd. · 2016 · 4 generations on21descendants
- K181612Tyto Stethoscope (OTC)Tyto Care, Ltd. · 2018 · 5 generations on19descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K961937 | Simulscope Auscultation and Simulscope Bedside Auscultation System | Delphi Consulting Group | 1996 | — |
| +1 | K991367 | Meditron Stethoscope System | Meditron AS | 1999 | — |
| +2 | K072026 | RNK Electronic Stethoscope | Rnk Products, Inc. | 2007 | — |
| +3 | K102893 | PCP/PC Stethoscope | Rnk Products, Inc. | 2011 | — |
| +4 | K160401 | Tyto Stethoscope | Tyto Care, Ltd. | 2016 | — |
| +5 | K181612 | Tyto Stethoscope (OTC) | Tyto Care, Ltd. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | — | Graphic Auscultation System Named without a submission number | |
| * | — | DEP-200 Digital Stethoscope Named without a submission number |
What descends from it? (52)
See all 521 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K991367 | Meditron Stethoscope System | 1999 | 51 |
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?
- Of its descendants, K991367 (Meditron AS, 1999) has gone furthest, with 51 descendants of its own.
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 SimulScope® Bedside Auscultation System allows the user to amplify heart, lung and bowel sounds and transmit them via infrared energy to wireless headphone worn by more then one listener. The system uses an electronic stethoscope connected to a transmitter unit and a receiving unit(s) for each listener.
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/K961937 · printed Nov 4, 2026
Cite this page
510(k) Report. “K961937: Simulscope Auscultation and Simulscope Bedside Auscultation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K961937
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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