# K103516: Audicor Sensor-Adapter Model Audicor Sensor-Adapter 4.0

- Pathway: 510(k) (Traditional)
- Applicant: Inovise Medical, Inc.
- Decided: Feb 4, 2011 after 66 days
- Product code: DQD (Stethoscope, Electronic)
- Device class: 2
- Regulation: 21 CFR 870.1875
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K961301 (1996). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080602: Audicor Sensor, Models: 2.0, 3.0, Inovise Medical, Inc. (2008) Summary page 1.

## Indications for use
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.

Source page: https://510kreport.com/device/K103516
Methodology: https://510kreport.com/methodology