# K013367: Cardiocollect Portable Electrocardiograph

- Pathway: 510(k) (Traditional)
- Applicant: Reynolds Medical, Ltd.
- Decided: Dec 13, 2001 after 64 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: 1 generation back to K002459 (2000). 1 ancestor in all.
8 later devices descend from it; 3 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002459: Pagewriter 10/10I, Model M2662A Handheld Electrocardiograph, Agilent Technologies, Inc. (2000) Summary page 1.

## Most influential descendants
- K024283: Cardiodirect, Models 12M, 12I, 12S (2003), 4 descendants of its own
- K053083: Datrix Cardio Wifi Electrocardiograph (2005), 2 descendants of its own
- K103427: Mobileecg System (2011), 1 descendant of its own
- K093211: Carecenter MD (2010), 1 descendant of its own
- K142349: TM eCloud ECG Analysis System (2015), 0 descendants of its own

## Indications for use
CardioCollect is a small, portable rechargeable-battery-powered digital electrocardiograph intended to be used by technicians to acquire 12-lead ECG’s from up to 40 patients, and then print them or store them digitally in the patient’s record in a computer (or both). The unit prints by direct connection to a printer. The unit meets all specifications for 12-lead electrocardiographs and has a provision for entry of patient data using its keypad.

Source page: https://510kreport.com/device/K013367
Methodology: https://510kreport.com/methodology