510(k) · Cleared
ClearedCardiosleeve
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rijuven Corp · DQD Stethoscope, Electronic
Cleared on Jun 24, 2013 as substantially equivalent to K110704 (Diacoustic Medical Devices (Pty), Ltd., 2011) after a 49-day review. Its family tree reaches back 9 generations to 1991. 1 later device descends from it.
- Decided
- Jun 24, 2013
- Review
- 49 days
- Class
- Class II
- Product code
- DQD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K910772 (1991). 50 ancestors in all, the oldest K771653 (1977). 1 later device descends from it, 1 citing it directly.
- Root · 9 generations backK910772 Propaq 102, 104 and 106Protocol Systems, Inc. · 1991
- 5 generations between
- 3 generations backK043359 4100 Patient Oximeter ModuleNonin Medical, Inc. · 2005
- 2 generations backK083309 Zargis Acoustic Cardioscan, Version 9.33Zargis Medical Corp. · 2009
- 1 generation backK110704 SENSIDiacoustic Medical Devices (Pty), Ltd. · 2011
- This deviceK131287 CardiosleeveRijuven Corp · 2013
- Descendant · cites it directly · 0 of its ownK201299 HD StethHd Medical, Inc. · 2020
Show all 9 generations
- Root · 9 generations backK910772 Propaq 102, 104 and 106Protocol Systems, Inc. · 1991
- 8 generations backK972020 Oscillomate Non-Invasive Blood Pressure MonitorCas Medical Systems, Inc. · 1998
- 7 generations backK980879 Oscillomate Nibp / SP02 Ems MonitorCas Medical Systems, Inc. · 1998
- 6 generations backK982776 9303 Neonatal/Adult Vital Signs MonitorCas Medical Systems, Inc. · 1998
- 5 generations backK013319 Nonin Model 2120 Pulse Oximeter and Noninvasive Blood Pressure…Nonin Medical, Inc. · 2002
- 4 generations backK041156 Avant Digital Pulse Oximetry System, Models 4000, 4001Nonin Medical, Inc. · 2004 · Recalled
- 3 generations backK043359 4100 Patient Oximeter ModuleNonin Medical, Inc. · 2005
- 2 generations backK083309 Zargis Acoustic Cardioscan, Version 9.33Zargis Medical Corp. · 2009
- 1 generation backK110704 SENSIDiacoustic Medical Devices (Pty), Ltd. · 2011
- This deviceK131287 CardiosleeveRijuven Corp · 2013
Most influential descendants
Showing 1 of 1 · See all- K201299HD StethHd Medical, Inc. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K910772 | Propaq 102, 104 and 106 | Protocol Systems, Inc. | 1991 | — |
| −8 | K972020 | Oscillomate Non-Invasive Blood Pressure Monitor | Cas Medical Systems, Inc. | 1998 | — |
| −7 | K980879 | Oscillomate Nibp / SP02 Ems Monitor | Cas Medical Systems, Inc. | 1998 | — |
| −6 | K982776 | 9303 Neonatal/Adult Vital Signs Monitor | Cas Medical Systems, Inc. | 1998 | — |
| −5 | K013319 | Nonin Model 2120 Pulse Oximeter and Noninvasive Blood Pressure (Nibp) Monitor | Nonin Medical, Inc. | 2002 | — |
| −4 | K041156 | Avant Digital Pulse Oximetry System, Models 4000, 4001 | Nonin Medical, Inc. | 2004 | 1 |
| −3 | K043359 | 4100 Patient Oximeter Module | Nonin Medical, Inc. | 2005 | — |
| −2 | K083309 | Zargis Acoustic Cardioscan, Version 9.33 | Zargis Medical Corp. | 2009 | — |
| −1 | K110704 | SENSI | Diacoustic Medical Devices (Pty), Ltd. | 2011 | — |
| 0 (this device) | K131287 | Cardiosleeve | Rijuven Corp | 2013 | — |
| +1 | K201299 | HD Steth | Hd Medical, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1977 | 1 | 0 |
| 1986 | 1 | 0 |
| 1990 | 1 | 0 |
| 1992 | 3 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 7 | 0 |
| 1997 | 3 | 0 |
| 1998 | 4 | 0 |
| 1999 | 3 | 0 |
| 2000 | 2 | 0 |
| 2001 | 3 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 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 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? (1)
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 |
|---|---|---|---|
| * | K110704 | SENSISummary page 1…Class 1l 807.92(a)(3) Legally Marketed Equivalent Device Company Product 510(k) # Diacoustic Medical Devices (Pty) Ltd Sensi with Diagnostic Heart Murmur Software K110704 K131287 P2/4 DEVICE DESCRIPTION ‘ 807.92(a)(4) The CardioSleeve with Diagnostic Heart Murmur Application, (appl… | 2011 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K201299 | HD Steth | 2020 | 0 |
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 6 companies; a new generation was cleared every 2.4 years on median.
- 2 of the 50 ancestors have a recall of any class.
- Of its descendants, K201299 (Hd Medical, Inc., 2020) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K110704.
How does its category compare?
All DQD devicesDQD Stethoscope, Electronic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
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 CardioSleeve System consisting of the CardioSleeve Front-End stethoscope with integrated ECG device, mobile heart sound and ECG recording application and the remote diagnostic heart murmur software is a decision support device intended to be used on a single patient to assist the qualified clinician in analyzing cardiac sounds and electrical signals for the identification and classification including of suspected murmurs. It is used to distinguish…
Read the full statement (258 words)
The CardioSleeve System consisting of the CardioSleeve Front-End stethoscope with integrated ECG device, mobile heart sound and ECG recording application and the remote diagnostic heart murmur software is a decision support device intended to be used on a single patient to assist the qualified clinician in analyzing cardiac sounds and electrical signals for the identification and classification including of suspected murmurs. It is used to distinguish between normal/physiological and pathological heart murmurs by recording the acoustic signal of the heart and the ECG signal simultaneously and analyzing these signals. The acoustic heart signal is analyzed to identify specific heart sounds that may be present. Identified sounds include S1, S2, and suspected murmurs.
CardioSleeve indicates whether or not a recorded heart sound contains a suspected heart murmur. The device must be used in a clinical setting by trained personnel with the prescribed accessories and all relevant patient information must be taken into consideration before a diagnosis is made.
The interpretations of heart sounds offered by the CardioSleeve device are only significant when used in conjunction with physician over-read as well as consideration of all other relevant patient data.
CardioSleeve is not intended to be a diagnostic device. It does not supersede the judgment of the clinician. The device is intended to aid the physician in the evaluation of heart sounds. The clinicians are responsible for reviewing and interpreting the results, along with the auscultatory findings and medical history, when making a referral decision.
Caution; Federal (USA) law restricts this device to sale by or on the-order of a clinician
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/K131287 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131287: Cardiosleeve.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131287
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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