# K254119: Wearable ECG Recorder (YMHeart XY-12); Wearable ECG Recorder (YMHeart XY-1201); Wearable ECG Recorder (YMHeart XY-1202); Wearable ECG Recorder (YMHeart XY-1203); Wearable ECG Recorder (YMHeart XY-03); Wearable ECG Recorder (YMHeart XY-0301); Wearable ECG Recorder (YMHeart XY-0302); Wearable ECG Recorder (YMHeart XY-0303)

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Xinyan Medical Technology Co.,ltd.
- Decided: Sep 11, 2026 after 266 days
- Product code: MWJ (Electrocardiograph, Ambulatory (Without Analysis))
- 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: 8 generations back to K963725 (1997). 61 ancestors in all.
No later device cites it as a predicate yet.
0 of 62 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151787: Holter System, Edan Instruments, Inc. (2016) Summary page 5.

## Indications for use
Wearable ECG Recorder is intended to acquire, record and store continuous ECG data as directed by a clinician from patients aged 18 and older for a maximum recording time of 7 days in a hospital, clinic or home environment. At the end of the recording, the recorded ECG data can be transferred in the ECG Management Software on PC via the USB connection.

Source page: https://510kreport.com/device/K254119
Methodology: https://510kreport.com/methodology