# K042463: Holter Plus

- Pathway: 510(k) (Traditional)
- Applicant: Rozinn Electronics, Inc.
- Decided: Sep 22, 2004 after 9 days
- Product code: DQK (Computer, Diagnostic, Programmable)
- Device class: 2
- Regulation: 21 CFR 870.1425
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K881905 (1988). 5 ancestors in all.
35 later devices descend from it; 2 cite it directly.
0 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K930564: Holter for Windows, North East Monitoring, Inc. (1995) Summary page 1.
- K012686: Caird Technology Holter 2000, Caird Technology (2001) Summary page 1.
- K881905: Model Micro SI Ambulatory Ecg Monitor, Advanced Medical Products, Inc. (1988) Summary page 1.
- K002544: Medilog Excel 2 - Holter Management System, Oxford Instruments (2000) Summary page 1.
- K884152: Century Color Trace, Biomedical Systems, Inc. (1988) Summary page 1.

## Most influential descendants
- 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
- K181502: Zio AT ECG Monitoring System, ZEUS System (2018), 12 descendants of its own

## Indications for use
The Holter PlusTM Ambulatory ECG Analysis System is intended for general hospital or clinical use by medical professionals whenever it is required to assess a patient's ambulatory ECG data. This product allows a trained physician or health care professional, after having performed a long-term continuous electrocardiograph (ECG) recording on a digital flash memory Holter recorder, to download and analyze the data from the recorder, review it and produce printed reports. This will enable the evaluation of arrhythmias, ischemic attacks, reporting of PQRST intervals, clinical and epidemiological research studies, evaluation of a patients response after resuming occupational or recreational activities (e.g., after MI. or cardiac surgery, and/or evaluation of patients with pacemakers. The need to record, review, edit and archive these ambulatory ECG data is most commonly encountered in the Cardiology areas of the hospital during cardiac patient assessment. This device is available for sale only upon the order of a physician or other related licensed medical professional, and not intended for any home use applications.

Source page: https://510kreport.com/device/K042463
Methodology: https://510kreport.com/methodology