# K031320: EK-Pro Arrhythmia Detection Algorithm

- Pathway: 510(k) (Special)
- Applicant: Ge Medical Systems Information Technologies
- Decided: May 6, 2003 after 11 days
- Product code: MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K001359 (2000). 2 ancestors in all.
42 later devices descend from it; 3 cite it directly.
1 of 45 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020290: Dash 3000/4000 Patient Monitor, General Electric Medical Systems Information Techn (2002)

## Most influential descendants
- K102239: Carescape Monitor B650 (2010), 32 descendants of its own
- K132533: Carescape Monitor B450 (2013), 14 descendants of its own
- K131223: Carescape Monitor B650 (2013), 13 descendants of its own
- K190008: Carescape One (2019), 11 descendants of its own
- K200494: CARESCAPE ONE and CARESCAPE DOCK FO, CARESCAPE ECG, CARESCAPE TEMP, CARESCAPE PRES (2020), 10 descendants of its own

## Indications for use
The EK-Pro Arrhythmia Detection Algorithm is intended for use under the direct supervision of a licensed healthcare practitioner. The intended use of the EK-Pro Algorithm is to monitor ECG parameter data on adult, pediatric and neonatal patients. The EK-Pro Algorithm is designed to monitor ECG parameter data in bedside, portable, and transport monitors that can operate in all professional medical facilities and medical transport modes.

Source page: https://510kreport.com/device/K031320
Methodology: https://510kreport.com/methodology