# K052511: Cardiofax CE, Model Ecg-1500 a

- Pathway: 510(k) (Traditional)
- Applicant: Nihon Kohden America, Inc.
- Decided: May 24, 2006 after 252 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
No predicates in its family tree.
17 later devices descend from it; 1 cites 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)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K072217: Ecg-1250A Series Cardiofax S and Ecg-1350A Series Cardiofax M (2007), 16 descendants of its own
- K090367: SE-601 Series Electrocardiograph (2009), 13 descendants of its own
- K093869: SE-601 Series Electrocardiograph (2010), 10 descendants of its own
- K131503: SE-601 Series Electrocardiograph (2014), 9 descendants of its own
- K160876: PC ECG (2017), 8 descendants of its own

## Indications for use
The Cardiofax V electrocardiograph is intended for medical purposes to process the electrical signals transmitted through two or more electrocardiograph electrodes to produce a patient record (monitor and recorder) and prepare a record and/or provide wireless transmission of data to a remote printer and/or computer. For non-interpretive applications, the device is intended for use with a full range of patient populations as determined by a clinician. The devices also provide an interpretive ECG program intended for use with patients age 3 years and older. The interpretation program is intended to provide an assessment of ECG waveform rhythm and morphology to assist the physician in diagnosis. Assessments provided by the interpretation program are not intended as the sole basis for diagnosis. All assessments provided by the interpretation program are recommended for review by qualified physicians trained in electrocardiography.

Source page: https://510kreport.com/device/K052511
Methodology: https://510kreport.com/methodology