# K012686: Caird Technology Holter 2000

- Pathway: 510(k) (Traditional)
- Applicant: Caird Technology
- Decided: Dec 13, 2001 after 121 days
- Product code: DPS (Electrocardiograph)
- Device class: 2
- Regulation: 21 CFR 870.2340
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
38 later devices descend from it; 2 cite it directly.
0 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K042463: Holter Plus (2004), 35 descendants of its own
- K091075: Zeus (Zio Ecg Utilization Service) System (2009), 32 descendants of its own
- K142681: ZEUS (ZIO ECG Utilization Service) System (2014), 31 descendants of its own
- K143513: ZIO SR ECG Monitoring Service (2015), 30 descendants of its own
- K163512: Zio AT ECG Monitoring System (2017), 18 descendants of its own

## Indications for use
Designed for Adult and Pediatric Patients. For Hospital and Clinic use only. Some of the conditions for use are as follows: Evaluation of Symptoms suggesting arrhythmia or myocardial ischemia. Evaluation of ECG documentation therapeutic intervention in individual or groups of patients. Evaluation of patieats for ST segment Changes Evaluation of patients response after resuming occupational or recreational activities (e.g. after M.I. or cardiac surgery). Evaluation of clinical syndromes or situations where arrhythmia may increase the risk of sudden death. Clinical and epidemiological research studies. Precaution: Computerized ECG Analysis should not replace diagnosis by a qualified physician. The physician should verify that the reported data is accurate before applying clinical conclusions.

Source page: https://510kreport.com/device/K012686
Methodology: https://510kreport.com/methodology