# K073545: Audicor, Hemo Ambulatory Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Inovise Medical, Inc.
- Decided: Sep 9, 2008 after 266 days
- Product code: MWJ (Electrocardiograph, Ambulatory (Without Analysis))
- 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: 2 generations back to K001317 (2000). 2 ancestors in all.
11 later devices descend from it; 3 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021470: Seer Light Compact Digital Holter Recorder, General Electric Medical Systems Information Techn (2002) Summary page 2.

## Most influential descendants
- K192004: Eko Analysis Software (2020), 4 descendants of its own
- K110569: Audicor Cpam (Cardiopulmonary Ambulatory Monitor) (2011), 4 descendants of its own
- K213794: Eko Murmur Analysis Software (EMAS) (2022), 3 descendants of its own
- K120462: Audicor Cpam with SDB (Cardiopulmonary Ambulatory Monitor with Sleep Disordered Breathing Detection) (2012), 3 descendants of its own
- K240901: Stethophone (2024), 1 descendant of its own

## Indications for use
The Audicor® System, when used with AUDICOR Sensors on the chest wall, is intended for use in acquiring, analyzing and reporting ECG and heart sound data and to provide interpretation of the data in an integrated ACG (acoustic cardiograph) report for consideration by physicians. Audicor systems allow detection, reporting and interpretation of standard ECG data as well as advanced parameters such as EMAT, LVST, S3 strength, S4 strength, and SDI. Data may be reported in a single snapshot report and in a trended report format where multiple data points are trended over time. The Audicor system also accepts and analyzes downloads of up to 48 hours of patient data from an optional ambulatory ECG/heart sounds collection device. 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 and is for use on adults (> 18 years).

Source page: https://510kreport.com/device/K073545
Methodology: https://510kreport.com/methodology