510(k) · Cleared
ClearedAudicor Sensor, Models: 2.0, 3.0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Inovise Medical, Inc. · DRX Electrode, Electrocardiograph
Cleared on Sep 25, 2008 as substantially equivalent to K030316 (Inovise Medical, Inc., 2003) after a 206-day review. Its family tree reaches back 2 generations to 1996. 1 later device descends from it.
- Decided
- Sep 25, 2008
- Review
- 206 days
- Class
- Class II
- Product code
- DRX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K961301 (1996). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK961301 E-Scope Electronic Stethoscope Model 718-7120Delphi Consulting Group · 1996
- 1 generation backK030316 Audicor Cor Sensor (and Accessory Adaptor)Inovise Medical, Inc. · 2003
- This deviceK080602 Audicor Sensor, Models: 2.0, 3.0Inovise Medical, Inc. · 2008
- Descendant · cites it directly · 0 of its ownK103516 Audicor Sensor-Adapter Model Audicor Sensor-Adapter 4.0Inovise Medical, Inc. · 2011
Most influential descendants
Showing 1 of 1 · See all- K103516Audicor Sensor-Adapter Model Audicor Sensor-Adapter 4.0Inovise Medical, Inc. · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K961301 | E-Scope Electronic Stethoscope Model 718-7120 | Delphi Consulting Group | 1996 | — |
| −1 | K030316 | Audicor Cor Sensor (and Accessory Adaptor) | Inovise Medical, Inc. | 2003 | — |
| 0 (this device) | K080602 | Audicor Sensor, Models: 2.0, 3.0 | Inovise Medical, Inc. | 2008 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 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 DRX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K030316 | Audicor Cor Sensor (and Accessory Adaptor) | 2003 |
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 |
|---|---|---|---|
| K103516 | Audicor Sensor-Adapter Model Audicor Sensor-Adapter 4.0 | 2011 | 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 12 years and passes through 2 companies; a new generation was cleared every 7.2 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K103516 (Inovise Medical, Inc., 2011) has gone furthest, with 0 descendants of its own.
How does its category compare?
All DRX devicesDRX Electrode, Electrocardiograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · DRX
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · DRX
78in 2010
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DRX
6in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DRX
250in 2025
MAUDE reports naming product code DRX, 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 | 3 | 147 | 0 | 47 |
| 2008 | 3 | 17 | 0 | 15 |
| 2009 | 7 | 89 | 0 | 36 |
| 2010 | 5 | 78 | 4 | 48 |
| 2011 | 0 | — | 0 | 80 |
| 2012 | 0 | — | 0 | 41 |
| 2013 | 1 | — | 0 | 70 |
| 2014 | 1 | — | 0 | 27 |
| 2015 | 0 | — | 1 | 58 |
| 2016 | 0 | — | 0 | 37 |
| 2017 | 1 | — | 0 | 55 |
| 2018 | 0 | — | 0 | 43 |
| 2019 | 0 | — | 0 | 50 |
| 2020 | 0 | — | 5 | 53 |
| 2021 | 0 | — | 1 | 55 |
| 2022 | 0 | — | 6 | 61 |
| 2023 | 0 | — | 0 | 113 |
| 2024 | 0 | — | 0 | 61 |
| 2025 | 0 | — | 0 | 250 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Audicor® Sensors are a family of dual-function sensors for use on adult patients (> 18 years) for acquisition of both heart sounds and ECG electrical signals and to transmit these signals to a compatible Audicor system to allow for the evaluation of patient status, to aid in diagnosis, and to determine effects of treatment on ECG and hemodynamics.
There are disposable and reusable versions of the Audicor Sensor. Both can be used in the collection of resting ECG reports. The disposable Audicor Sensor is also intended for longer term monitoring applications of up to 48 hours.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080602 · printed Nov 3, 2026
Cite this page
510(k) Report. “K080602: Audicor Sensor, Models: 2.0, 3.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080602
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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