# K232670: HiCardi+ H100

- Pathway: 510(k) (Traditional)
- Applicant: MEZOO Co., Ltd.
- Decided: Sep 20, 2024 after 385 days
- Product code: DSH (Recorder, Magnetic Tape, Medical)
- 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: 7 generations back to K963725 (1997). 27 ancestors in all.
No later device cites it as a predicate yet.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143513: ZIO SR ECG Monitoring Service, iRhythm Technologies, Inc. (2015) Summary page 5.

## Indications for use
The HiCardi+ H100 is intended to record symptomatic and asymptomatic cardiac events and continuous electrocardiogram (ECG) for 72 hours from ambulatory patients by attaching HiCardi+ H100 SmartPatch to the skin surface. ECG records are stored in SmartPatch for review by the clinician after the recording period (up to 72 hours) is completed. It is indicated for use on 22 years or older who may be symptomatic and/or asymptomatic or suffer from transient symptoms as palpitations, shortness of breath, dizziness, light-headedness, fatigue, or anxiety. The reported ECG metrics include preliminary indications of the irregular beat and/or rhythm and heart rate measurement based on a single-lead ECG basis. The arrhythmia information addressed in the report does not contain diagnostic interpretation; the reported indication is provided for review by the intended user to make a diagnosis based on clinical judgment and experience.

Source page: https://510kreport.com/device/K232670
Methodology: https://510kreport.com/methodology