# K092663: Eli 350 Electrocardiograph

- Pathway: 510(k) (Abbreviated)
- Applicant: Mortara Instrument, Inc.
- Decided: Dec 14, 2009 after 105 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: 7 generations back to K921669 (1993). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 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 1.
- K022618: X-Scribe II, Mortara Instrument, Inc. (2002) Summary page 1.
- K073625: Modification to: Mac 5500 Resting Ecg Analysis System, Ge Healthcare Systems Information Technologies (2008) Summary page 1.

## 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 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. The device is indicated for use to acquire, analyze, display and print signal-averaged ECGs to detect ventricular late potentials for consideration by a physician. The device is indicated for use to acquire, process, record, archive, analyze, display and print ECG data of patients undergoing physiologic stress exercise testing.

Source page: https://510kreport.com/device/K092663
Methodology: https://510kreport.com/methodology