# K990170: Holter 2000

- Pathway: 510(k) (Special)
- Applicant: Zymed Medical Instrumentation
- Decided: Apr 13, 1999 after 84 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: 2 generations back to K930806 (1994). 2 ancestors in all.
89 later devices descend from it; 4 cite it directly.
0 of 92 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K955015: Zymed Holter Scanner Model 2010, Zymed Medical Instrumentation (1996) Summary page 1.

## Most influential descendants
- K010949: 2010 Plus Holter for Windows (2001), 85 descendants of its own
- 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

## 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.

Source page: https://510kreport.com/device/K990170
Methodology: https://510kreport.com/methodology