# K030316: Audicor Cor Sensor (and Accessory Adaptor)

- Pathway: 510(k) (Traditional)
- Applicant: Inovise Medical, Inc.
- Decided: Aug 7, 2003 after 189 days
- Product code: DRX (Electrode, Electrocardiograph)
- Device class: 2
- Regulation: 21 CFR 870.2360
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K961301 (1996). 2 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K953649: Disposable Ecg Electrode, Kendall-Ltp (1996) Summary page 2.
- K961301: E-Scope Electronic Stethoscope Model 718-7120, Delphi Consulting Group (1996) Summary page 2.

## Most influential descendants
- K080602: Audicor Sensor, Models: 2.0, 3.0 (2008), 1 descendant of its own
- K103516: Audicor Sensor-Adapter Model Audicor Sensor-Adapter 4.0 (2011), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K030316
Methodology: https://510kreport.com/methodology