510(k) · Cleared
ClearedCardioscope Sonoplus 3000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pulsonic Ag, Medical Technology · DPS Electrocardiograph
Cleared on May 19, 2005 as substantially equivalent to K990809 (Caditec AG, 1999) after a 16-day review. Its family tree reaches back 2 generations to 1995.
- Decided
- May 19, 2005
- Review
- 16 days
- Class
- Class II
- Product code
- DPS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K954066 (1995). 3 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K954066 | Miniscope MS-3 | Schiller America, Inc. | 1995 | — |
| −1 | K990809 | Cadiscope Electronic Stethoscope | Caditec AG | 1999 | — |
| 0 (this device) | K051126 | Cardioscope Sonoplus 3000 | Pulsonic Ag, Medical Technology | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 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 DPS? 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 DPS device
- #1 K212112 Cardiologs Holter Platformscore 18.6 · 5 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K990809 | Cadiscope Electronic StethoscopeSummary page 1…ardiograph 9-Device Classification Name: Electrocardiograph 1O-Substantial Equivalency is claimed against the following device: CADITEC's CADISCOPE, 510k #K990809 11 -Description of the Device: This device SONOPLUS 3000 is a combination product that includes Electrocardiograph and manual St… | 1999 |
| Kept off the family tree | K980105 | Unnamed device Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 2…attached. Indeed, this device is SIMILAR to the predicate device. REFER TO MAIN SUBMISSION FOR COMPLETE DETAILS FDA file reference number 510k# K980105 Attachments inside notification submission file 510Ok summary print out TECHNOLOGICAL CHARACTERISTICS Compar… |
What descends from it?
No later submission names this one as a predicate yet.
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 10 years and passes through 3 companies; a new generation was cleared every 5.9 years on median.
- None of the 3 ancestors has a recall.
- 5 other devices also cite its predicate K990809.
How does its category compare?
All DPS devicesDPS Electrocardiograph: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DPS
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DPS
163in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DPS
3in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · DPS
55in 2025
MAUDE reports naming product code DPS, 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 | 11 | 87 | 2 | 9 |
| 2008 | 13 | 31 | 0 | 17 |
| 2009 | 14 | 84 | 1 | 14 |
| 2010 | 11 | 104 | 2 | 21 |
| 2011 | 22 | 154 | 1 | 121 |
| 2012 | 12 | 117 | 0 | 56 |
| 2013 | 10 | 134 | 0 | 15 |
| 2014 | 11 | 253 | 0 | 15 |
| 2015 | 8 | 178 | 0 | 30 |
| 2016 | 11 | 229 | 0 | 12 |
| 2017 | 9 | 177 | 0 | 15 |
| 2018 | 14 | 221 | 0 | 19 |
| 2019 | 3 | 178 | 9 | 27 |
| 2020 | 6 | 224 | 2 | 59 |
| 2021 | 5 | 135 | 1 | 24 |
| 2022 | 6 | 244 | 1 | 59 |
| 2023 | 10 | 236 | 3 | 54 |
| 2024 | 8 | 260 | 4 (1) | 64 |
| 2025 | 6 | 163 | 3 | 55 |
| 2026 | 6 | 258 | 4 | — |
What is it indicated for?
This device is a patented combination device that includes Electrocardiograph and manual Stethoscope with an integrated graphics display of ECG signal, heart rate, presence of a pacemaker, as well as a standard acoustic stethoscope that reduces interference ("Anti-Interference System") This device is intended for use as a diagnostic aid as part of physical assessment of patient by healthcare professionals or other individuals trained to administer…
Read the full statement (160 words)
This device is a patented combination device that includes Electrocardiograph and manual Stethoscope with an integrated graphics display of ECG signal, heart rate, presence of a pacemaker, as well as a standard acoustic stethoscope that reduces interference ("Anti-Interference System")
This device is intended for use as a diagnostic aid as part of physical assessment of patient by healthcare 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, measuring, storing and transmitting to a database the 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.
SONOPLUS 3000 is not intended for use in intensive care. Simultaneous use with defibrillators is prohibited.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051126 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051126: Cardioscope Sonoplus 3000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051126
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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