# K130207: Spacelabs Healthcare Cardioexpress

- Pathway: 510(k) (Traditional)
- Applicant: Spacelabs Healthcare, Ltd.
- Decided: Jul 23, 2013 after 176 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 K921669 (1993). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090367: SE-601 Series Electrocardiograph, Edan Instruments, Inc. (2009) Summary page 2.
- K091513: Smart Ecg Series Electrocardiograph, Models SE-3, SE-300A and 300B, SE-6, SE-600, SE-12, SE-12 Express and SE-1200, Edan Instruments, Inc. (2009) Summary page 2.

## Indications for use
The intended use of the Spacelabs Healthcare CardicExpress (CardicExpress) is to acquire ECG signals from adult and pediatric patients using ECG electrodes. CardiaExpress is only intended to be used in hospitals or healthcare facilities by doctors and trained healthcare professionals. The cardiogram recorded by CardioExpress can help users to analyze and diagnose heart disease. However, the interpreted ECG with measurements and interpretive statements are only intended to be used on adult patients, and is offered to clinicians on an advisory basis only.

Source page: https://510kreport.com/device/K130207
Methodology: https://510kreport.com/methodology