# K032145: Audicor Upgrade System

- Pathway: 510(k) (Traditional)
- Applicant: Inovise Medical, Inc.
- Decided: Oct 31, 2003 after 109 days
- Product code: DPS (Electrocardiograph)
- Device class: 2
- Regulation: 21 CFR 870.2340
- 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 K920626 (1992). 3 ancestors in all.
13 later devices descend from it; 3 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031182: Eli 200+ Audicor, Mortara Instrument, Inc. (2003). Cleared while this submission was under review

## Most influential descendants
- K112432: Zoll X Series (2012), 8 descendants of its own
- K133269: Zoll X Series (2014), 4 descendants of its own
- K121367: Zoll Propaq XM (2012), 3 descendants of its own
- K180482: ZOLL Propaq M (2018), 2 descendants of its own
- K141774: Zoll X Series (2014), 2 descendants of its own

## Indications for use
The AudicorTM Upgrade System, when used with Audicor Sensors in the V3 and V4 positions on the chest wall, is intended for use in acquiring, analyzing and reporting ECG and heart sounds (phonocardiograph) data and to provide interpretation of the data for consideration by physicians. The Audicor System is an add-on device designed to work with the following electrocardiographs: GE Mac 8 GE Mac Vu GE Mac 5000 Philips Pagewriter XL 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 all 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/K032145
Methodology: https://510kreport.com/methodology