510(k) · Cleared
ClearedAudicor Cor Sensor (and Accessory Adaptor)
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 Aug 7, 2003 as substantially equivalent to K953649 (Kendall-Ltp, 1996) and 1 other predicate after a 189-day review. Its family tree reaches back 1 generation to 1996. 2 later devices descend from it.
- Decided
- Aug 7, 2003
- Review
- 189 days
- Class
- Class II
- Product code
- DRX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K961301 (1996). 2 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK961301 E-Scope Electronic Stethoscope Model 718-7120Delphi Consulting Group · 1996
- This deviceK030316 Audicor Cor Sensor (and Accessory Adaptor)Inovise Medical, Inc. · 2003
- Descendant · cites it directly · 1 of its ownK080602 Audicor Sensor, Models: 2.0, 3.0Inovise Medical, Inc. · 2008
- Descendant · 2 generations on · 0 of its ownK103516 Audicor Sensor-Adapter Model Audicor Sensor-Adapter 4.0Inovise Medical, Inc. · 2011
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K961301 | E-Scope Electronic Stethoscope Model 718-7120 | Delphi Consulting Group | 1996 | — |
| 0 (this device) | K030316 | Audicor Cor Sensor (and Accessory Adaptor) | Inovise Medical, Inc. | 2003 | — |
| +1 | K080602 | Audicor Sensor, Models: 2.0, 3.0 | Inovise Medical, Inc. | 2008 | — |
| +2 | 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 |
|---|---|---|
| 2008 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K953649 | Disposable Ecg ElectrodeSummary page 2…Substantial The lnovise Medical Audicor Sensor is substantially Equivalence: equivalent to the Kendall-LTP Disposable ECG electrode (K953649) and the E-Scope Electronic Stethoscope. Technological The table below contains the comparison of features and Character… | 1996 |
| * | K961301 | E-Scope Electronic Stethoscope Model 718-7120Summary page 2…peration between the Audicor Sensor and other selected predicate devices. 510(k) Identifier I KO30316 1 K953649 1 K961301 I Meets EC12-2000 Standard I Yes I Yes I No I… | 1996 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K080602 | Audicor Sensor, Models: 2.0, 3.0 | 2008 | 1 |
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 DRX devicesDRX Electrode, Electrocardiograph: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 AudicorTMSensor is a single-use, disposable medical device designed for short duration contact (up to 1 hour) for use at the V4 ECG electrode position to acquire both heart sounds and ECG electrical signals when attached to the body surface of a resting, adult (18+ years of age) patient, and to transmit these signals to compatible electrocardiographs and physiological recorders/monitors. Such equipment is commonly located in hospitals, doctor's offices and emergency vehicles.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030316 · printed Nov 5, 2026
Cite this page
510(k) Report. “K030316: Audicor Cor Sensor (and Accessory Adaptor).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K030316
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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