Cleared Traditional

K261569 - UbiqVue 2AYe Cardiac System (UX2253)

K261569 is an FDA 510(k) clearance for UbiqVue 2AYe Cardiac System (UX2253), manufactured by Lifesignals, Inc.. The device is a Class 2 Cardiovascular device with product code DRG cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K261569 · Lifesignals, Inc. · Cardiovascular device
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Jul 2026
Decision
58d
Days
Class 2
Risk

K261569 is an FDA 510(k) clearance for the UbiqVue™ 2AYe Cardiac System (UX2253). Classified as Transmitters And Receivers, Physiological Signal, Radiofrequency (product code DRG), Class II - Special Controls.

Submitted by Lifesignals, Inc. (Milpitas, US). The FDA issued a Cleared decision on July 9, 2026 after a review of 58 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2910 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Lifesignals, Inc. devices

FDA 510(k) Submission Details - K261569

510(k) Number K261569 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 2026
Decision Date July 09, 2026
Days to Decision 58 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 125d · This submission: 58d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRG Device Classification - Class 2, Special Controls

Product Code DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2910
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DRG Transmitters And Receivers, Physiological Signal, Radiofrequency

All 74
Devices cleared under the same product code (DRG) and FDA review panel - the closest regulatory comparables to K261569.
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