# K043074: Liberty System

- Pathway: 510(k) (Traditional)
- Applicant: Inovise Medical, Inc.
- Decided: Feb 22, 2005 after 106 days
- Product code: DPS (Electrocardiograph)
- Device class: 2
- Regulation: 21 CFR 870.2340
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K920626 (1992). 4 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032145: Audicor Upgrade System, Inovise Medical, Inc. (2003) Summary page 1.
- K031182: Eli 200+ Audicor, Mortara Instrument, Inc. (2003) Summary page 2.

## Most influential descendants
- K051450: Extended Measurements System (2005), 1 descendant of its own
- K070136: Audicor 200 System, Models 200D and 200S (2007), 0 descendants of its own

## Recalls of this device
- Jan 12, 2003 · Not classified · Z-0565-06: Use of the AUDICOR 200 D in-line with a defibrillator/monitor resulted in interruption of pacing therapy to a patient when the AUDICOR 200 D stopped working due to low battery power.

## Indications for use
The Liberty 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 COR report for consideration by physicians. The Liberty System can be used as an add-on device to work in conjunction with select cardiographs, defibrillators, and patient monitors; or as a stand-alone electrocardiograph. The interpretations of 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/K043074
Methodology: https://510kreport.com/methodology