# K261569: UbiqVue™ 2AYe Cardiac System (UX2253)

- Pathway: 510(k) (Traditional)
- Applicant: Lifesignals, Inc.
- Decided: Jul 9, 2026 after 58 days
- Product code: DRG (Transmitters And Receivers, Physiological Signal, Radiofrequency)
- Device class: 2
- Regulation: 21 CFR 870.2910
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K882803 (1988). 79 ancestors in all.
No later device cites it as a predicate yet.
0 of 80 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200690: LifeSignals ECG Remote Monitoring Patch Platform, Lifesignals, Inc. (2020) Summary page 6.
- K163512: Zio AT ECG Monitoring System, iRhythm Technologies, Inc. (2017) Summary page 6.

## Indications for use
The UbiqVue™ 2AYe Cardiac System is intended to capture, record for analysis and report both symptomatic and asymptomatic cardiac events, along with continuous electrocardiogram (ECG) information, for long-term monitoring. Following patient monitoring using the UbiqVue™ 2AYe Wearable Biosensor, a comprehensive final report is generated from the entire ECG recording. Optionally, intended users may choose to generate an interim report from periodically or intermittently transferred ECG recording wirelessly from the UbiqVue™ 2AYe Wearable Biosensor. Final & interim reporting is based on the beat-to-beat information extracted from the ECG recording. The UbiqVue™ 2AYe Cardiac System is intended for non-critical, adult population, who are 18 years of age or older, at home and in healthcare settings, who may be asymptomatic or who may suffer from transient symptoms such as palpitations, shortness of breath, dizziness, light-headedness, pre-syncope, syncope, fatigue, or anxiety. The reports are provided for review by the intended user to render a diagnosis based on their clinical judgment and experience.

Source page: https://510kreport.com/device/K261569
Methodology: https://510kreport.com/methodology