# K024283: Cardiodirect, Models 12M, 12I, 12S

- Pathway: 510(k) (Traditional)
- Applicant: Reynolds Medical, Ltd.
- Decided: Aug 1, 2003 after 221 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 K921669 (1993). 13 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013367: Cardiocollect Portable Electrocardiograph, Reynolds Medical, Ltd. (2001)
- K002074: AB Cardiette Daedalus View Base and AB Cardiettte Daedalus View Hes, H&C Medical Devices Spa (2000)
- K014108: Mac 5000 Ecg Analysis System, General Electric Medical Systems Information Techn (2002)
- K011339: Quest Exercise Stress System, Model Configuration 14, Spacelabs Burdick, Inc. (2001)

## Most influential descendants
- K093211: Carecenter MD (2010), 1 descendant of its own
- K123217: Cardeascreen (2013), 0 descendants of its own
- K082380: Vicardio 12B (2008), 0 descendants of its own
- K062469: Voyager 12 (2006), 0 descendants of its own

## Indications for use
The use of CardioDirect is indicated when it is desired to record and interpret an electrocardiogram of a patient. This includes a resting electrocardiogram, a rhythm electrocardiogram, or a stress electrocardiogram (such as might be taken during an exercise stress test).

Source page: https://510kreport.com/device/K024283
Methodology: https://510kreport.com/methodology