Cleared Traditional

OptoMonitor 3

K251367 · Opsens, Inc. · Cardiovascular
Jan 2026
Decision
260d
Days
Class 2
Risk

About This 510(k) Submission

K251367 is an FDA 510(k) clearance for the OptoMonitor 3, a Transducer, Pressure, Catheter Tip (Class II — Special Controls, product code DXO), submitted by Opsens, Inc. (Quebec, CA). The FDA issued a Cleared decision on January 16, 2026, 260 days after receiving the submission on May 1, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2870.

Submission Details

510(k) Number K251367 FDA.gov
FDA Decision Cleared SESE
Date Received May 01, 2025
Decision Date January 16, 2026
Days to Decision 260 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DXO — Transducer, Pressure, Catheter Tip
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2870