# K252839: ZywieZ3 Sensor & Adhesive

- Pathway: 510(k) (Traditional)
- Applicant: Zywie, Inc.
- Decided: Jun 18, 2026 after 286 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: 7 generations back to K950944 (1996). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210758: Q Patch, Medicalgorithmics S.A. (2022) Summary page 5.

## Indications for use
The ZywieZ3 Sensor is a wireless device intended for use by healthcare professionals to record and display physiological data for patients requiring outpatient cardiac monitoring, both at home and in healthcare settings. When used with the ZywieZ3 Adhesive, the device captures electrocardiogram (ECG) data and wirelessly transmits it to a separate device- such as a mobile phone- for storage, display, and transmission. This is an ambulatory, continuous recording system designed for general patient care. It is not intended for critical care patients and does not replace standard clinical monitoring practices. Instead, it provides physiological data recordings for later review by healthcare professionals. The device is not intended to provide real-time interpretative or diagnostic information.

Source page: https://510kreport.com/device/K252839
Methodology: https://510kreport.com/methodology