# K062469: Voyager 12

- Pathway: 510(k) (Special)
- Applicant: Del Mar Reynolds Medical, Ltd.
- Decided: Nov 3, 2006 after 71 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). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 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.
- K946281: Eclipse 4 Electrocardiograph, Burdick, Inc. (1996) Summary page 1.

## Indications for use
The use of Voyager 12 is indicated when it is desired to record and interpret an electrocardiogram of a patient. This includes a resting electrocardiogram and a rhytlun electrocardiogram,

Source page: https://510kreport.com/device/K062469
Methodology: https://510kreport.com/methodology