# K100127: Eli 230 Electrocardiograph

- Pathway: 510(k) (Abbreviated)
- Applicant: Mortara Instrument, Inc.
- Decided: Apr 16, 2010 after 87 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: 2 generations back to K920626 (1992). 3 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 10 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) Summary page 1.

## Most influential descendants
- K123556: Mortara Surveyor Patient Monitor (2013), 2 descendants of its own
- K120865: Rscribe Electrocardiograph (2012), 2 descendants of its own
- K161517: Mortara Surveyor Patient Monitor (2017), 1 descendant of its own
- K260250: QCA 10 Electrocardiograph (QCARD-10); QCA 10W Electrocardiograph (QCARD-10W) (2026), 0 descendants of its own
- K173765: Surveyor Patient Monitor (2018), 0 descendants of its own

## Recalls of this device
- Mar 18, 2020 · Class II · Z-1810-2020: Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment.

## Indications for use
The ELI 230 Electrocardiograph is a non-invasive prescription device. * The Mortara ELI 230 Electrocardiograph is indicated for use to acquire, analyze, display and print electrocardiograms. * The device is indicated for use for patients of any age, diseased or non-diseased. * The device is indicated for use to provide interpretation of the data for consideration by a physician. * 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 in a clinical setting, by qualified medical professionals, properly trained for EGG monitoring and use of the system. The personnel must be experienced in cardiovascular problematic situations and emergency procedures or pathologies related to cardiac involvements. It is not intended as a.sole means of diagnosis. * The device is not intended' to be used as a vital signs physiological monitor. * The cardiac data and analysis provided is reviewed, confirmed, and used by trained medical personnel in the diagnosis of patients with various rhythm patterns.

Source page: https://510kreport.com/device/K100127
Methodology: https://510kreport.com/methodology