# K003763: 2010 Plus Holter for Windows

- Pathway: 510(k) (Special)
- Applicant: Agilent Technologies
- Decided: Jan 5, 2001 after 30 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: 3 generations back to K930806 (1994). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990170: Holter 2000, Zymed Medical Instrumentation (1999) Summary page 1.
- K984089: Zymed Telemetry System, Model Easi View, Zymed Medical Instrumentation (1999) Summary page 1.

## Indications for use
Assessment of symptoms that may be related to thythm disturbances of the heart in patients from pediatric to adult age. Patients with palpitations. Assessment of risk in Patients With or Without Symptoms of Arrhythmia. Patients with symptomatic or asymptomatic idiopathic hypertrophic cardiomyopathy and postmyocardial infarction patient with left ventricular dysfunction using arrhythmia e.g.: ventricular ectopy, as method of risk assessment. Assessment of efficacy of Antiarrhythmia Therapy. Patients with baseline high frequency, reproducible, sustained, symptomatic premature ventricular complexes supraventricular arrhythmia or ventricular tachycardia. Assessment of Pacemaker Function. Evaluation of patients with paroxysmal symptoms, detection of myopotential inhibition, detection of pacemaker mediated tachycardia, evaluation of antitachycardia pacing device function, evaluation of rate-responsive physiological pacing function. Detection of Myocardial Ischemia. Patients with chest pain suggestive of Prinzmetal’s angina. Assessment of EASI derived 12-lead ST measurements is recommended for patients that meet the following parameters. 1. Ages: 33 to 82 years 2. Heights: 147 to 185 cm (58 to 73 in) 3. Weights: 53 to 118 kg (117 to 261 Ib) Height to Weight ratios: 1.41 to 2.99 cm/kg ( 0.25 to 0.54 in/1b.)

Source page: https://510kreport.com/device/K003763
Methodology: https://510kreport.com/methodology