# K242018: UbiqVue™ 2A Multi-parameter System (UX2550)

- Pathway: 510(k) (Traditional)
- Applicant: Lifesignals, Inc.
- Decided: Nov 12, 2024 after 125 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: 21 generations back to K962603 (1997). 167 ancestors in all.
2 later devices descend from it; 2 cite it directly.
1 of 170 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202868: LifeSignals Multi-Parameter Remote Monitoring Platform, Lifesignals, Inc. (2021) Summary page 6.
- K212153: Biobeat Platform, BB-613WP Patch, Biobeat Technologies, Ltd. (2022) Summary page 6.

## Most influential descendants
- K260157: LifeLens Physiological Monitor (2026), 0 descendants of its own
- K252984: Perin Health System (PHD80060-2) (2026), 0 descendants of its own

## Indications for use
The UbiqVue 2A Multiparameter System is a wireless remote patient monitoring system intended for use by healthcare professionals for continuous collection of physiological data at home and in healthcare settings. This shall include electrocardiography (2-Channel ECG), heart Rate, SpO2%, respiration rate, pulse Rate, photoplethysmography waveform, skin temperature, body temperature, body posture, body motion, R-R Interval, heart Rate variability (HRV) and blood Pressure (optional). Data is transmitted wirelessly near real time from UbiqVue 2A Wearable Biosensor and 3rd party device (for Blood Pressure only) to remote central server for display, storage, and analysis. The UbiqVue 2A Multiparameter System is intended for non-critical, adult population. The UbiqVue 2A Multiparameter System shall include the ability to notify healthcare professionals through alerts when physiological parameters fall outside the set limits, manual trigger by the patient and to display multiple patient's physiological data for remote monitoring at home and with visual alarm for active monitoring at hospitals and out-of-hospital patient care settings (such as clinics, outpatient surgery facilities, long-term care facilities and physician offices) in which care is administered by healthcare professionals.

Source page: https://510kreport.com/device/K242018
Methodology: https://510kreport.com/methodology