# K131883: Audicor Cpam with SDB (Accelerometer Based)

- Pathway: 510(k) (Traditional)
- Applicant: Inovise Medical, Inc.
- Decided: Apr 11, 2014 after 290 days
- Product code: MNR (Ventilatory Effort Recorder)
- Device class: 2
- Regulation: 21 CFR 868.2375
- 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). 44 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 46 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 2.

## Most influential descendants
- K151433: AUDICOR CA300/CC100 Analyzer with SDB (2016), 0 descendants of its own

## Indications for use
The AUDICOR System when used with AUDICOR Sensors on the chest wall and properly attached Holler unit, is intended for use on adults 18 years of age and older in acquiring, analyzing and reporting ECG, heart sound. sleep-disordered breathing (SOB) and snaring detection and to provide interpretation of the data in an integrated report for consideration by physicians. The SOB 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 polysamnography based on the patients score. Patients screened for SOB 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 bya 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/K131883
Methodology: https://510kreport.com/methodology