# K010949: 2010 Plus Holter for Windows

- Pathway: 510(k) (Traditional)
- Applicant: Agilent Technologies
- Decided: Sep 28, 2001 after 183 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). 4 ancestors in all.
85 later devices descend from it; 5 cite it directly.
0 of 90 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.
- K981024: QT Dispersion and T Wave Analysis Program (QT Guard Analysis System), Marquette Medical Systems, Inc. (1998) Summary page 1.

## Most influential descendants
- K042108: Vista Plus (2005), 46 descendants of its own
- K071641: Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient Assistant (Model 9539) (2007), 40 descendants of its own
- K071655: Reveal DX Insertable Cardiac Monitor, Reveal Patient Assistant, Model (S) 9528,9538 (2007), 30 descendants of its own
- K082475: Reveal XT Insertable Cardiac Monitor, Model 9529, Revel DX Insertable Cardiac Monitor, Model 9528 (2008), 28 descendants of its own
- K103764: Reveal XT Insertable Cardiac Monitor, Model 9529 and Reveal DX Insertable Cardiac Monitor, Model 9528 (2011), 26 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 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) 4. Height to Weight ratios: 1.41 to 2.99 cm/kg ( 0.25 to 0.54 in/Ib.) QT measurements can be used by the physician in risk assessment process indicated for patients with and without symptoms of arrhythmia. QT measurement is intended to be used by competent health professionals in hospital or clinic environment. Composite QT measures the interval only and is not intended to produce any interpretation or diagnosis of those measurements.

Source page: https://510kreport.com/device/K010949
Methodology: https://510kreport.com/methodology