# K082380: Vicardio 12B

- Pathway: 510(k) (Traditional)
- Applicant: Energy-Lab Technologies GmbH
- Decided: Dec 3, 2008 after 106 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). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 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.
- K013367: Cardiocollect Portable Electrocardiograph, Reynolds Medical, Ltd. (2001) Summary page 1.

## Indications for use
The vicardiol2b is indicated for the recording of resting electrocardiograms (ECG), and for making measurements on the electrocardiograms, by a physician or under the direction of a physician.

Source page: https://510kreport.com/device/K082380
Methodology: https://510kreport.com/methodology