# K243003: VitalSigns 1-Lead Holter (VSH101)

- Pathway: 510(k) (Traditional)
- Applicant: VitalSigns Technology Co., Ltd.
- Decided: Jun 17, 2025 after 264 days
- Product code: DXH (Transmitters And Receivers, Electrocardiograph, Telephone)
- Device class: 2
- Regulation: 21 CFR 870.2920
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K882803 (1988). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193296: eCordum Cardiac Monitor (eCordum CM), Ecordum, Inc. (2020) Summary page 5.

## Indications for use
The VSH101 is designed to record, transmit, and store single channel electrocardiogram (ECG) data via Bluetooth communication to compatible Bluetooth enabled devices. The device is intended for use by healthcare professionals, individuals with known or suspected cardiac conditions, and health-conscious users. The ECG data serves as a supplementary source of patient information and is not intended for automated analysis.

Source page: https://510kreport.com/device/K243003
Methodology: https://510kreport.com/methodology