# K072217: Ecg-1250A Series Cardiofax S and Ecg-1350A Series Cardiofax M

- Pathway: 510(k) (Special)
- Applicant: Nihon Kohden America, Inc.
- Decided: Aug 30, 2007 after 21 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 K984504 (1999). 2 ancestors in all.
16 later devices descend from it; 3 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052511: Cardiofax CE, Model Ecg-1500 a, Nihon Kohden America, Inc. (2006) Summary page 1.
- K984504: Nihon Kohden Ecg-9110K and Ecg-9130K Cardiofax Q and Accessories, Nihon Kohden America, Inc. (1999) Summary page 1.

## Most influential descendants
- 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
- K171942: Electrocardiograph (2018), 3 descendants of its own

## Indications for use
The ECG-1250A Series Cardiofax S and ECG-1350A Series Cardiofax M Electrocardiographs are intended to monitor the patient's heart rate electrically, the devices have been developed as the devices to select the operators, amplify, record or measure the electric potential captured by the electrodes attached to the patient's thoracic and extremities parts. Based on the information output by the devices, the devices will help the doctors for their cardiovascular diagnostication. For non-interpretive applications, the ECG-1250A Series Cardiofax S and ECG-1350A Series Cardiofax M Electrocardiographs are 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 are 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. Qualified physicians trained in electrocardiography recommend all assessments provided by the interpretation programs for review.

Source page: https://510kreport.com/device/K072217
Methodology: https://510kreport.com/methodology