Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

UbiqVue™ 2AYe Cardiac System (UX2253)

K-Number: K261569 · 2026-07-09

ApplicantLifesignals, Inc.
Decision Date2026-07-09
Product CodeDRG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

UbiqVue™ 2AYe Cardiac System (UX2253) is the device name listed in this FDA 510(k) record. The listed applicant is Lifesignals, Inc.. It received FDA 510(k) clearance on 2026-07-09 under 510(k) number K261569. The device is classified under product code DRG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UbiqVue™ 2AYe Cardiac System (UX2253)?

UbiqVue™ 2AYe Cardiac System (UX2253) is a medical device that received FDA 510(k) clearance on 2026-07-09. The listed applicant is Lifesignals, Inc.. The 510(k) number is K261569.

When did UbiqVue™ 2AYe Cardiac System (UX2253) receive FDA 510(k) clearance?

UbiqVue™ 2AYe Cardiac System (UX2253) received FDA 510(k) clearance on 2026-07-09, under 510(k) number K261569.

Who is the listed applicant for UbiqVue™ 2AYe Cardiac System (UX2253)?

The FDA 510(k) record lists Lifesignals, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UbiqVue™ 2AYe Cardiac System (UX2253)?

The FDA product code for UbiqVue™ 2AYe Cardiac System (UX2253) is DRG.

Other records listing Lifesignals, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K242018UbiqVue™ 2A Multi-parameter System (UX2550)K202868LifeSignals Multi-Parameter Remote Monitoring PlatformK200690LifeSignals ECG Remote Monitoring Patch Platform

Related Devices (Code: DRG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252984Perin Health System (PHD80060-2)Perin Health Devices, LLCK252440EasyTeleMed (2.0.2)Ingeniars S.R.L.K250259TeleRehab Aermos Cardiopulmonary RehabilitationThe ScottCare CorporationK243837iBSMIorbit Digital Technologies Private LimitedK242018UbiqVue™ 2A Multi-parameter System (UX2550)Lifesignals, Inc.K241101BioButton SystemBiointellisense, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑