510(k) · Cleared
ClearedAudicor Sensor-Adapter Model Audicor Sensor-Adapter 4.0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Inovise Medical, Inc. · DQD Stethoscope, Electronic
Cleared on Feb 4, 2011 as substantially equivalent to K080602 (Inovise Medical, Inc., 2008) after a 66-day review. Its family tree reaches back 3 generations to 1996.
- Decided
- Feb 4, 2011
- Review
- 66 days
- Class
- Class II
- Product code
- DQD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K961301 (1996). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK961301 E-Scope Electronic Stethoscope Model 718-7120Delphi Consulting Group · 1996
- 2 generations backK030316 Audicor Cor Sensor (and Accessory Adaptor)Inovise Medical, Inc. · 2003
- 1 generation backK080602 Audicor Sensor, Models: 2.0, 3.0Inovise Medical, Inc. · 2008
- This deviceK103516 Audicor Sensor-Adapter Model Audicor Sensor-Adapter 4.0Inovise Medical, Inc. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K961301 | E-Scope Electronic Stethoscope Model 718-7120 | Delphi Consulting Group | 1996 | — |
| −2 | K030316 | Audicor Cor Sensor (and Accessory Adaptor) | Inovise Medical, Inc. | 2003 | — |
| −1 | K080602 | Audicor Sensor, Models: 2.0, 3.0 | Inovise Medical, Inc. | 2008 | — |
| 0 (this device) | K103516 | Audicor Sensor-Adapter Model Audicor Sensor-Adapter 4.0 | Inovise Medical, Inc. | 2011 | — |
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 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 |
|---|---|---|---|
| * | K080602 | Audicor Sensor, Models: 2.0, 3.0Summary page 1…rs (Sensor 2.0 and Sensor 4.0) 2) Reusable sensors (Sensor 3.0) Predicate Device: AUDICOR Tm 2.0 Sensor -510(k) K080602 Inovise Medical, Inc. 510(k) Notification, Modification to AUDICOR Sensors 14 of… | 2008 |
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 15 years and passes through 2 companies; a new generation was cleared every 5.1 years on median.
- None of the 4 ancestors has a recall.
How does its category compare?
All DQD devicesDQD Stethoscope, Electronic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 AudicorT Sensors with Adapters are a family of dual-function transducers for use on patients where combined EGG/headt sounds data are needed for the evaluation of patient status, to aid in diagnosis and determine effects of treatment on ECG and hemodynamics. Audicor Sensors with Adapters may be used only with a compatible Audicor System.
There are disposable and reusable versions of the Audicor Sensor component. Both can be used in the recording of resting EGG / headt sound repodts. The disposable Audicor Sensor is also intended for longer term monitoring applications of up to 46 hours.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103516 · printed Nov 5, 2026
Cite this page
510(k) Report. “K103516: Audicor Sensor-Adapter Model Audicor Sensor-Adapter 4.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K103516
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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