# K093211: Carecenter MD

- Pathway: 510(k) (Traditional)
- Applicant: Cardiac Science Corporation
- Decided: Jun 3, 2010 after 233 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). 25 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K024283: Cardiodirect, Models 12M, 12I, 12S, Reynolds Medical, Ltd. (2003) Summary page 1.
- K031561: Cardiosoft/Case Cardiac Testing System, Ge Medical Systems Information Technologies (2003) Summary page 1.
- K051534: Cardioline AR 600, AR 1200, AR 2100, Et Medical Devices Spa (2005) Summary page 1.
- K974149: Ambulatory X-12 Telemetry Module, Mortara Instrument, Inc. (1998) Summary page 1.

## Most influential descendants
- K123217: Cardeascreen (2013), 0 descendants of its own

## Indications for use
The Cardiac Science CareCenter MD is intended to be used by trained operators under the direct supervision of a licensed healthcare practitioner on adult and pediatric populations. The device is designed to acquire, display, process, record, analyze and output 12 lead ECG data during periods of physiological stress, induced through exercise or pharmacological means or during resting EGG testing. In addition, the CareCenter MD provides interfaces for acquiring physiological data from ancillary devices (such as spirometry and blood pressure) and records EGG in real time with and without arrhythmia detection. The system provides automatic interpretation of resting EGG on adult populations. No automatic interpretation of resting EGGs is provided for pediatric populations. Interpretive statements should be overviewed and approved by trained physicians. The CareCenter MD may provide interfaces for the control of external devices such as a treadmill or an ergometer, and for communicating with centralized computer systems via a network. The device is intended to provide non-diagnostic patient data management functions as both a self-contained, stand-alone application and by interfacing with Electronic Medical Records systems. The device is not intended to be used as a vital signs or long term physiological monitor. The CareCenter MD is not intended to be used as a transport device.

Source page: https://510kreport.com/device/K093211
Methodology: https://510kreport.com/methodology