# K060766: Portable,  Electrocardiograph (Ecg) Monitor, Model HCG-801

- Pathway: 510(k) (Traditional)
- Applicant: Omron Healthcare, Inc.
- Decided: Jun 9, 2006 after 79 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
Longest line of descent: 1 generation back to K992696 (1999). 1 ancestor in all.
55 later devices descend from it; 11 cite it directly.
0 of 57 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992696: Ecg Minimonitor, Model CG-5000, Card Guard Scientific Survival, Ltd. (1999) Summary page 1.

## Most influential descendants
- K093872: Handheld Ecg Monitor, Model MD100 (2010), 37 descendants of its own
- K111438: REKA E100 (2011), 32 descendants of its own
- K121628: Epi Mini Ecg Portable Health Monitoring System (Epi Mini) (2013), 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
The Omron HCG-801 portable ECG Monitor is intended for recording and displaying ECG data by adult patients who are concerned about their heart rhythm. This Omron HCG-801 portable ECG Monitor allows the consumer to record their ECG data into the device memory for display by healthcare professionals during office visits. Specifically, Omron HCG-801 portable ECG Monitor is intended for adult patients who are concerned about their heart rhythm or have experienced the following symptoms that are suggestive of abnormal heart rhythm: -Skipped beats -Pounding heart (palpitations) -History of arrhythmia

Source page: https://510kreport.com/device/K060766
Methodology: https://510kreport.com/methodology