Cleared Traditional

UbiqVue? 2A Multi-parameter System (UX2550)

K242018 · Lifesignals, Inc. · Cardiovascular

Nov 2024

Decision

125d

Days

Class 2

Risk

About This 510(k) Submission

K242018 is an FDA 510(k) clearance for the UbiqVue? 2A Multi-parameter System (UX2550), a Transmitters And Receivers, Physiological Signal, Radiofrequency (Class II — Special Controls, product code DRG), submitted by Lifesignals, Inc. (Milpitas, US). The FDA issued a Cleared decision on November 12, 2024, 125 days after receiving the submission on July 10, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2910.

Submission Details

510(k) Number	K242018 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 10, 2024
Decision Date	November 12, 2024
Days to Decision	125 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF

Device Classification

Product Code	DRG — Transmitters And Receivers, Physiological Signal, Radiofrequency
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 870.2910