# K003940: 2010 Plus Holter for Windows

- Pathway: 510(k) (Special)
- Applicant: Agilent Technologies
- Decided: Feb 8, 2001 after 49 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). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
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.
- K895208: Zymed Model 1610, Agilent Technologies (1989) Summary page 1.
- K974192: Biosensor Holter Monitor System, Biosensor Corp. (1998) Summary page 1.

## Most influential descendants
- K142349: TM eCloud ECG Analysis System (2015), 0 descendants of its own

## Indications for use
Assessment of symptoms that may be related to rhythm 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 supraventncular 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.

Source page: https://510kreport.com/device/K003940
Methodology: https://510kreport.com/methodology