# K122073: Eli 280 Electrocardiograph

- Pathway: 510(k) (Special)
- Applicant: Mortara Instrument, Inc.
- Decided: Aug 2, 2012 after 17 days
- Product code: DPS (Electrocardiograph)
- Device class: 2
- Regulation: 21 CFR 870.2340
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K933143 (1994). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101403: Eli 250 Electrocardiograph, Mortara Instrument, Inc. (2010) Summary page 1.

## Recalls of this device
- Sep 3, 2021 · Class II · Z-0011-2022: The devices malfunction under specific operator workflows.
- Mar 31, 2021 · Class II · Z-1482-2021: Devices do not meet IEC 60601-2-27 requirements as labeled.

## Indications for use
The proposed Mortara ELI 280 Electrocardiograph is a non-invasive prescription device. 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/K122073
Methodology: https://510kreport.com/methodology