UbiqVue 2AYe Cardiac System (UX2253)— 510(k) K261569

Name: FDA 510(k) clearance K261569
Creator: U.S. Food and Drug Administration
Published: 2026-07-09

Substantially Equivalent

Lifesignals, Inc.

FDA 510(k) clearance K261569 for UbiqVue 2AYe Cardiac System (UX2253), Substantially Equivalent on 2026-07-09. Applicant: Lifesignals, Inc.. Device class: 2.

Clearance details

Applicant: Lifesignals, Inc.
Product code: Code DRG
Device class: Class 2
Regulation: 21 CFR 870.2910
Advisory panel: Cardiovascular
Date received: 2026-05-12
Decision date: 2026-07-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Milpitas, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code DRG

product code DRG

Death: 5
Total: 5

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.