# K080602: Audicor Sensor, Models: 2.0, 3.0

- Pathway: 510(k) (Traditional)
- Applicant: Inovise Medical, Inc.
- Decided: Sep 25, 2008 after 206 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: 2 generations back to K961301 (1996). 3 ancestors in all.
1 later device descends 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)
- K030316: Audicor Cor Sensor (and Accessory Adaptor), Inovise Medical, Inc. (2003)

## Most influential descendants
- K103516: Audicor Sensor-Adapter Model Audicor Sensor-Adapter 4.0 (2011), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K080602
Methodology: https://510kreport.com/methodology