510(k) · Cleared
ClearedCadiscope Electronic Stethoscope
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Caditec AG · DQD Stethoscope, Electronic
Cleared on Jun 9, 1999 as substantially equivalent to K961301 (Delphi Consulting Group, 1996) and 1 other predicate after a 90-day review. Its family tree reaches back 1 generation to 1995. 66 later devices descend from it.
- Decided
- Jun 9, 1999
- Review
- 90 days
- Class
- Class II
- Product code
- DQD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K954066 (1995). 2 ancestors in all. 66 later devices descend from it, 6 citing it directly.
- Root · 1 generation backK954066 Miniscope MS-3Schiller America, Inc. · 1995
- This deviceK990809 Cadiscope Electronic StethoscopeCaditec AG · 1999
- Descendant · cites it directly · 46 of its ownK013434 VP-2000/1000Colin Corp. · 2002
- Descendant · 2 generations on · 27 of its ownK082357 Microlife Upper Arm Automatic Digital Blood Pressure Monitor…Microlife Intellectual Property GmbH · 2008
- Descendant · cites it directly · 16 of its ownK013725 Meditron II Thesterthoscope SystemMeditron AS · 2002
- Descendant · 3 generations on · 15 of its ownK151869 Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH, Switzerland · 2015
- Descendant · 2 generations on · 13 of its ownK110704 SENSIDiacoustic Medical Devices (Pty), Ltd. · 2011
Showing 5 of 66 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 66 · See all- K013434VP-2000/1000Colin Corp. · 2002 · cites it directly46descendants
- K082357Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Modelwatchbp Office…Microlife Intellectual Property GmbH · 2008 · 2 generations on27descendants
- K013725Meditron II Thesterthoscope SystemMeditron AS · 2002 · cites it directly16descendants
- K151869Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH, Switzerland · 2015 · 3 generations on15descendants
- K110704SENSIDiacoustic Medical Devices (Pty), Ltd. · 2011 · 2 generations on13descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K954066 | Miniscope MS-3 | Schiller America, Inc. | 1995 | — |
| 0 (this device) | K990809 | Cadiscope Electronic Stethoscope | Caditec AG | 1999 | — |
| +1 | K013434 | VP-2000/1000 | Colin Corp. | 2002 | — |
| +2 | K082357 | Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Modelwatchbp… | Microlife Intellectual Property GmbH | 2008 | — |
| +1 | K013725 | Meditron II Thesterthoscope System | Meditron AS | 2002 | — |
| +3 | K151869 | Microlife Upper Arm Automatic Digital Blood Pressure Monitor | Microlife Intellectual Property GmbH, Switzerland | 2015 | — |
| +2 | K110704 | SENSI | Diacoustic Medical Devices (Pty), Ltd. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 0 |
| 2005 | 3 | 0 |
| 2007 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
| 2010 | 5 | 0 |
| 2011 | 4 | 0 |
| 2012 | 3 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 3 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 3 | 0 |
| 2019 | 3 | 0 |
| 2020 | 4 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 6 | 0 |
| 2024 | 3 | 0 |
| 2025 | 4 | 0 |
| 2026 | 6 | 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 |
|---|---|---|---|
| * | K961301 | E-Scope Electronic Stethoscope Model 718-7120Summary page 2…nt to other electronic stethoscopes on the market. CADIscope claims for it's sound channel, substantial equivalence to the E-Scope Electronic Stethoscope Model 718-7120, K961301 manufactured by Cardionics Inc., 1100 Hercules Ave, Suite 210, Houston, 77058 TX. The CADIscope, with it's ECG display, is subst… | 1996 |
| * | K954066 | Miniscope MS-3Summary page 2…lent to other small portable electrocardiographs on the market. CADIscope claims for it's ECG display, substantial equivalence to the Miniscope MS-3, Electrocardiograph, K954066, manufactured by Schiller AG, Altgasse 68, CH-6340 Baar, Switzerland. COMPARISON TO PREDICATE DEVICE: The CADIscope is similar t… | 1995 |
What descends from it? (66)
See all 666 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?
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 CADIscope is a patented electronic stethoscope with an integrated graphics display to show the amplified heart sounds as phonocardiograms and show parallel to the heart sounds the ECG in an Einthoven Triangle. It is intended for use as a diagnostic aid as part of a physical assessment of a patient by health care professionals or other individuals trained to administer emergency first aid or otherwise care for a patient. It can be used for the…
Read the full statement (135 words)
The CADIscope is a patented electronic stethoscope with an integrated graphics display to show the amplified heart sounds as phonocardiograms and show parallel to the heart sounds the ECG in an Einthoven Triangle.
It is intended for use as a diagnostic aid as part of a physical assessment of a patient by health care professionals or other individuals trained to administer emergency first aid or otherwise care for a patient.
It can be used for the amplification of heart, lung, blood vessel, enteral and other body sounds. When the device’s integral electrodes are placed on the chest of the patient, it is capable of verifying the existence of cardiac biopotential activity. The quality of the biopotential activity display depends upon user technique and environmental conditions and it is in no way meant to be diagnostic.
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/K990809 · printed Nov 4, 2026
Cite this page
510(k) Report. “K990809: Cadiscope Electronic Stethoscope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K990809
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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