Cleared Traditional

OptoMonitor 3

K241418 · Opsens, Inc. · Cardiovascular
Feb 2025
Decision
268d
Days
Class 2
Risk

About This 510(k) Submission

K241418 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 February 12, 2025, 268 days after receiving the submission on May 20, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2870.

Submission Details

510(k) Number K241418 FDA.gov
FDA Decision Cleared SESE
Date Received May 20, 2024
Decision Date February 12, 2025
Days to Decision 268 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