# K130660: Audicor Cpam with SDB (Single Sensor)

- Pathway: 510(k) (Traditional)
- Applicant: Inovise Medical, Inc.
- Decided: Oct 11, 2013 after 213 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: 9 generations back to K910772 (1991). 47 ancestors in all.
No later device cites it as a predicate yet.
0 of 48 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120462: Audicor Cpam with SDB (Cardiopulmonary Ambulatory Monitor with Sleep Disordered Breathing Detection), Inovise Medical, Inc. (2012) Summary page 3.
- K011903: Lifeshirt System with Vivologic Analysis Software, Vivometrics, Inc. (2002) Summary page 3.

## Indications for use
The AUDICOR System when used with an AUDICOR Sensor on the chest wall and properly attached Halter unit is Intended for use on adults 18 yenr of age and older Inacquiring, analyzing and reporting ECG, heart sound, body position, Sleep Disordered Breathing (SDB) and snoring detection and to provide interpretation of the data in an integrated report for consideration by physicians. The 6DB 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. Patients screened for 6DB should have periods of sleep of at least 4 hours duration during which the ECG 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/K130660
Methodology: https://510kreport.com/methodology