# K024323: Century Series Holter Scanner System, Models C3000, C2000 and C1000

- Pathway: 510(k) (Traditional)
- Applicant: Biomedical Systems Corp.
- Decided: Jun 30, 2003 after 186 days
- Product code: MLO (Electrocardiograph, Ambulatory, With Analysis Algorithm)
- Device class: 2
- Regulation: 21 CFR 870.2800
- 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 K884152 (1988). 1 ancestor in all.
9 later devices descend from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K884152: Century Color Trace, Biomedical Systems, Inc. (1988) Summary page 1.

## Most influential descendants
- K053263: Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model CN1003 (2006), 8 descendants of its own
- K093288: Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection (2010), 7 descendants of its own
- K151787: Holter System (2016), 2 descendants of its own
- K153473: Braemar Telemetry Patch System (2016), 1 descendant of its own
- K133753: Mome Ecg Continuous Detection and Arrhythmia Detector (2014), 1 descendant of its own

## Indications for use
The Century Series Holter Scanner System, Model C3000/C2000/C1000 is intended for the replay and analysis of ECG data pre-recorded on compatible cassette tape or digital Holter recorders and is indicated for: Cardiac evaluation of heart rate and rhythm in patients experiencing syncope, near syncope, dizziness, palpitations, shortness of breath, chest pain and transient arrhythmias. To assess risk for future cardiac events in patients without symptoms from arrhythmia who have bee diagnosed with congestive heart failure, idiopathic hypertrophic cardiomyopathy, and post myocardial infarction with left ventricular dysfunction. Assessment of drug response in patients taking antiarrhythmic medications. Baseline frequency of the arrhythmia should be characterized as reproducible and of sufficient frequency to permit evaluation. ST segment analysis in patients with known coronary heart disease, chest pain, and suspected variant angina. Patient population: human beings without restrictions of age, sex, or race requiring analysis of 24 hour ambulatory ECG recordings as determined by a medical practitioner.

Source page: https://510kreport.com/device/K024323
Methodology: https://510kreport.com/methodology