# K151433: AUDICOR CA300/CC100 Analyzer with SDB

- Pathway: 510(k) (Traditional)
- Applicant: Inovise Medical, Inc.
- Decided: Mar 18, 2016 after 295 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: 10 generations back to K910772 (1991). 45 ancestors in all.
No later device cites it as a predicate yet.
0 of 46 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131883: Audicor Cpam with SDB (Accelerometer Based), Inovise Medical, Inc. (2014) Summary page 5.

## Indications for use
AUDICOR CA300/CC100 Analyzer with SDB is a software-only system intended to be used to analyze recordings from AUDICOR-compatible recording devices. AUDICOR CA300/CC100 Analyzer with SDB is capable of analyzing, editing, storing and reporting ECG, heart sound, sleep-disordered breathing (SDB), snoring detection, body position and activity level. An interpretation of the analysis results is produced in an integrated report for consideration by physicians. The AUDICOR CA300/CC100 Analyzer with SDB software is intended for use on adults 18 years of age and older. The SDB analysis and reporting is intended for use on adult patients 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 SDB should have periods of sleep of at least 4 hours duration. AUDICOR CA300/CC100 Analyzer with SDB is intended to be used by trained operators under the direct supervision of a physician in a hospital or clinic environment.

Source page: https://510kreport.com/device/K151433
Methodology: https://510kreport.com/methodology