# K110569: Audicor Cpam (Cardiopulmonary Ambulatory Monitor)

- Pathway: 510(k) (Traditional)
- Applicant: Inovise Medical, Inc.
- Decided: Oct 24, 2011 after 238 days
- Product code: MLO (Electrocardiograph, Ambulatory, With Analysis Algorithm)
- Device class: 2
- Regulation: 21 CFR 870.2800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K910870 (1991). 16 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073545: Audicor, Hemo Ambulatory Monitor, Inovise Medical, Inc. (2008) Summary page 2.
- K110001: Spacelabs Pathfinder SL Holter Analyzer, Spacelabs Healthcare, Ltd. (2011). Cleared while this submission was under review Summary page 2.

## Most influential descendants
- K120462: Audicor Cpam with SDB (Cardiopulmonary Ambulatory Monitor with Sleep Disordered Breathing Detection) (2012), 3 descendants of its own
- K131883: Audicor Cpam with SDB (Accelerometer Based) (2014), 1 descendant of its own
- K151433: AUDICOR CA300/CC100 Analyzer with SDB (2016), 0 descendants of its own
- K130660: Audicor Cpam with SDB (Single Sensor) (2013), 0 descendants of its own

## Indications for use
The Audicor® System, when used with AUDICOR Sensors on the chest wall and properly attached Holter unit, is intended for use on adults 18 years of age and older in acquiring, analyzing and reporting ECG and heart sound data and to provide interpretation of the data in an integrated report for consideration by physicians. The Audicor recording may be obtained at any location specified by a physician including home, hospital or clinic. The measurements provided and interpretations of ECG and heart sound data offered by the device are only significant when used in conjunction with physician over read as well as consideration of other relevant patient data. The device is intended for use only under the direct supervision of a physician.

Source page: https://510kreport.com/device/K110569
Methodology: https://510kreport.com/methodology