# K142105: Eli 380 Electrocardiograph

- Pathway: 510(k) (Special)
- Applicant: Mortara Instrument, Inc.
- Decided: Sep 5, 2014 after 35 days
- Product code: DPS (Electrocardiograph)
- Device class: 2
- Regulation: 21 CFR 870.2340
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K933143 (1994). 3 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082946: Mortara Eli 350 Electrocardiograph, Mortara Instrument, Inc. (2008) Summary page 4.

## Most influential descendants
- K173830: MAC VU360 Resting ECG Analysis System (2018), 3 descendants of its own
- K203786: MAC 7 - Resting ECG Analysis System (2021), 2 descendants of its own
- K251670: MAC 7 Resting ECG Analysis System (2026), 0 descendants of its own
- K221321: MAC 5 A4/ MAC 5 A5/ MAC 5 Lite Resting ECG Analysis System (2022), 0 descendants of its own

## Recalls of this device
- Oct 31, 2022 · Class II · Z-1013-2023: One ELI 380 Electrocardiograph intended to be used for a pilot program was shipped to a customer by mistake on 26 October 2022.
- Mar 31, 2021 · Class II · Z-1483-2021: Devices do not meet IEC 60601-2-27 requirements as labeled.
- May 29, 2015 · Class II · Z-1796-2015: Mortara Instrument, Inc. has recently become aware of a potential safety hazard involving our ELI 380 electrocardiograph. When used in a particular workflow, acquired ECG waveforms for one patient may

## Indications for use
The device is indicated for use to acquire, analyze, display and print electrocardiograms. The device is indicated for use to provide interpretation of the data for consideration by a physician. The device is indicated for use in a clinical setting, by a physician or by trained personnel who are acting on the orders of a licensed physician. It is not intended as a sole means of diagnosis. The interpretations of ECG offered by the device are only significant when used in conjunction with a physician over-read as well as consideration of all other relevant patient data. The device is indicated for use on adult and pediatric populations. The device is not intended to be used as a vital signs physiological monitor.

Source page: https://510kreport.com/device/K142105
Methodology: https://510kreport.com/methodology