# K120462: Audicor Cpam with SDB (Cardiopulmonary Ambulatory Monitor with Sleep Disordered Breathing Detection)

- Pathway: 510(k) (Traditional)
- Applicant: Inovise Medical, Inc.
- Decided: Sep 20, 2012 after 218 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: 8 generations back to K910772 (1991). 43 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 47 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110569: Audicor Cpam (Cardiopulmonary Ambulatory Monitor), Inovise Medical, Inc. (2011) Summary page 2.
- K110001: Spacelabs Pathfinder SL Holter Analyzer, Spacelabs Healthcare, Ltd. (2011)
- K082113: Nox T3, Noxturnal (PC Application), Nox Medical (2008) Summary page 2.

## Most influential descendants
- 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 Hoiter unit, is intended for use on adults 18 years of age and older in acquiring, analyzing and reporting EGG, heart sound, sleep disordered breathing and snoring detection and to provide interpretation of the data in an integrated report for consideration by physicians. The sleep disordered breathing analysis and reporting is intended for use on adult patients only as a screening device for obstructive or mixed apnea to determine the need for evaluation by polysomnography based on the patient's score. Subjects screened for sleep disordered breathing should have periods of sleep of at least 4 hours duration during which the EGG is predominantly sinus rhythm in nature. The AUDICOR recording may be obtained at any location specified by a physician including home, hospital or clinic. The device is intended for use only under the direct supervision of a physician.

Source page: https://510kreport.com/device/K120462
Methodology: https://510kreport.com/methodology