Cleared Traditional

K193620 - OptoMonitor 3

K193620 is an FDA 510(k) clearance for OptoMonitor 3, manufactured by Opsens, Inc.. The device is a Class 2 Cardiovascular device with product code DXO cleared through the Traditional 510(k) pathway after a 175-day FDA review.

K193620 · Opsens, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2020
Decision
175d
Days
Class 2
Risk

K193620 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 June 18, 2020 after a review of 175 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Opsens, Inc. devices

FDA 510(k) Submission Details - K193620

510(k) Number K193620 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 2019
Decision Date June 18, 2020
Days to Decision 175 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
50d slower than avg
Panel avg: 125d · This submission: 175d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXO Device Classification - Class 2, Special Controls

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 33
Devices cleared under the same product code (DXO) and FDA review panel - the closest regulatory comparables to K193620.
ACIST RXi System (016616)
K233904 · Acist Medical Systems, Inc. · Jul 2024
TruWave Disposable Pressure Transducer
K222216 · Edwards Lifesciences, LLC · Dec 2022
OptoMonitor 3
K202943 · Opsens, Inc. · Nov 2020
Comet II Pressure Guidewire
K193279 · Boston Scientific Corporation · Dec 2019
OptoMonitor
K192340 · Opsens, Inc. · Dec 2019
Zurich Pressure Guidewire System Model 100
K190852 · Zurich Medical, Inc. · Aug 2019