FDA 510(k) · LifeSignals
K261569: UbiqVue 2AYe Cardiac System (UX2253) (Lifesignals, Inc.)
Lifesignals, Inc. received FDA 510(k) K261569 for UbiqVue 2AYe Cardiac System (UX2253), with a decision date of Jul 9, 2026 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K261569 |
|---|---|
| Pathway | 510(k) |
| Applicant | Lifesignals, Inc. |
| Device name | UbiqVue 2AYe Cardiac System (UX2253) |
| Product code | DRG: Transmitters And Receivers, Physiological Signal, Radiofrequency |
| Regulation (21 CFR) | 870.2910 |
| Device class | Class 2 |
| Date received | May 12, 2026 |
| Decision date | Jul 9, 2026 |
| Decision | Substantially Equivalent (SESE) |
| 510(k) type | Traditional |
Source: openFDA device 510(k) data, data through Oct 26, 2026.
Indications for use parsed from FDA documents
• The UbiqVue™ 2AYe Cardiac System is intended to capture, record for analysis and report both symptomatic and asymptomatic cardiac events, along with continuous electrocardiogram (ECG) information, for long-term monitoring. Following patient monitoring using the UbiqVue™ Wearable Biosensor, a comprehensive final report is generated from the entire ECG recording. Optionally, intended users may choose to generate an interim report from periodically or intermittently transferred ECG recording wirelessly from the UbiqVue™ Wearable Biosensor. Final & interim reporting is based on the beat-to-beat information extracted from the ECG recording. • The UbiqVue™ 2AYe Cardiac system is intended for non-critical, adult population, who are 18 years of age or older, at home and in healthcare settings, who may be asymptomatic or who may suffer from transient symptoms such as palpitations, shortness of breath, dizziness, light-headedness, pre-syncope, syncope, fatigue, or anxiety. The reports are provided for review by the intended user to render a diagnosis based on their clinical judgment and experience. Rev C UbiqVue 2AYe Cardiac System
Extracted automatically from FDA's 510(k) summary. It can contain extraction errors and is not a verified quote. Read the wording in the FDA PDF before relying on it.
Predicates parsed from FDA documents
FDA numbers found next to the word "predicate" in the summary. The list can include reference devices; check the PDF for which device is the primary predicate.
ChatPPG interpretation
A 510(k) decision of "substantially equivalent" means FDA found the device as safe and effective as a legally marketed predicate. FDA's word for this is cleared, not approved. The clearance covers the device and indications in this submission; it does not extend to other features or versions of the same product that were not part of it. See FDA cleared vs approved.
Product code DRG is "Transmitters And Receivers, Physiological Signal, Radiofrequency", class 2, 21 CFR 870.2910.
Our labels for filtering: claim Remote / vital-sign monitoring, sensor Unknown. These are heuristics, not FDA fields.