UbiqVue 2AYe Cardiac System (UX2253)— 510(k) K261569
Substantially EquivalentLifesignals, Inc.
FDA 510(k) clearance K261569 for UbiqVue 2AYe Cardiac System (UX2253), Substantially Equivalent on 2026-07-09. Applicant: Lifesignals, Inc.. Device class: 2.
Summary
Lifesignals' UbiqVue 2AYe Cardiac System (UX2253) is filed under DRG, radiofrequency physiological signal transmitters and receivers. The record gives the model as UX2253 but doesn't say what signals it carries.
Class II, 21 CFR 870.2910. Cardiovascular is both the classification panel and the review panel. It was a Traditional 510(k).
Lifesignals filed from Milpitas, California. The decision came 58 calendar days after receipt (May 12 to July 9, 2026).
Clearance details
- Applicant
- Lifesignals, Inc.
- Product code
- Product code DRG
- Device class
- Class 2
- Regulation
- 21 CFR 870.2910
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Milpitas, CA, US
Recent devices under product code DRG
view allMore clearances from Lifesignals, Inc.
view allAdverse events under product code DRG
product code DRG- Death
- 5
- Total
- 5
Source: openFDA MAUDE database, through . 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.