Cleared Traditional

OptoMonitor 3 (K202943) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K202943 · Opsens, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2020
Decision
55d
Days
Class 2
Risk

K202943 is an FDA 510(k) clearance for the OptoMonitor 3. Classified as Transducer, Pressure, Catheter Tip (product code DXO), Class II - Special Controls.

Submitted by Opsens, Inc. (Quebec, CA). The FDA issued a Cleared decision on November 24, 2020 after a review of 55 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2870 - 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 Opsens, Inc. devices

Submission Details

510(k) Number K202943 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2020
Decision Date November 24, 2020
Days to Decision 55 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 125d · This submission: 55d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DXO Transducer, Pressure, Catheter Tip
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2870
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 - DXO Transducer, Pressure, Catheter Tip

All 19
Devices cleared under the same product code (DXO) and FDA review panel - the closest regulatory comparables to K202943.
OptoMonitor 3
K241418 · Opsens, Inc. · Feb 2025
ACIST RXi System (016616)
K233904 · Acist Medical Systems, Inc. · Jul 2024
TruWave Disposable Pressure Transducer
K222216 · Edwards Lifesciences, LLC · Dec 2022
OptoMonitor 3
K193620 · Opsens, Inc. · Jun 2020
Comet II Pressure Guidewire
K193279 · Boston Scientific Corporation · Dec 2019
OptoMonitor
K192340 · Opsens, Inc. · Dec 2019