# K110065: Spaulding IQ Electrocardiograph

- Pathway: 510(k) (Abbreviated)
- Applicant: Spaulding Clinical Research, LLC
- Decided: Mar 2, 2011 after 51 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: 4 generations back to K942704 (1994). 9 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093339: Eli PC Electrocardiograph, Mortara Instrument, Inc. (2010) Summary page 1.
- K082077: BT3/6, BT12, Corscience GmbH & Co. KG (2008) Summary page 1.

## Most influential descendants
- K150564: Spaulding Electrocardiograph 2100iQ (2015), 1 descendant of its own
- K163607: ECG Acquisition Systems (2017), 0 descendants of its own

## Indications for use
The IQ Electrocardiograph is a non-invasive prescription device that is indicated for use: * The proposed IQ Electrocardiograph is indicated for use to acquire, analyze, display and print electrocardiograms. * The device is indicated for use for pediatric and adult populations, diseased or non-diseased. The device is not indicated for use for neonatal (birth to 28 days) or infants (29 days up to 2 years). * The interpretations of ECG data 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. * It is not designed for out of hospital transport. * It is not designed for use in highly invasive environments, such as an operating theatre. * 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/K110065
Methodology: https://510kreport.com/methodology