# K150564: Spaulding Electrocardiograph 2100iQ

- Pathway: 510(k) (Traditional)
- Applicant: Spaulding Clinical Research, LLC
- Decided: Aug 12, 2015 after 159 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: 5 generations back to K942704 (1994). 10 ancestors in all.
1 later device descends 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)
- K110065: Spaulding IQ Electrocardiograph, Spaulding Clinical Research, LLC (2011) Summary page 4.

## Most influential descendants
- K163607: ECG Acquisition Systems (2017), 0 descendants of its own

## Indications for use
The Spaulding Electrocardiograph is intended to acquire a resting, diagnostic 12-lead ECG for display and subsequent upload to a Medical Device Data System (MDDS). This enables clinicians, or trained care personnel who are acting on the orders of a licensed physician, to acquire, process, display, store, and print diagnostic 12 lead ECGs. The Spaulding Electrocardiograph is for use on adult and pediatric populations, diseased or non-diseased and is not intended for use on neonatal (birth to 28 days) or infants (29 days up to 2 years). The device is not for use in highly invasive environments, or as a vital signs physiological monitor. The Spaulding Electrocardiograph provides un-interpreted 12-lead ECG data and is not to be a sole means of diagnosis.

Source page: https://510kreport.com/device/K150564
Methodology: https://510kreport.com/methodology