Cleared Traditional

K161263 - OptoMonitor II

K161263 is an FDA 510(k) clearance for OptoMonitor II, 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 131-day FDA review.

K161263 · Opsens, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2016
Decision
131d
Days
Class 2
Risk

K161263 is an FDA 510(k) clearance for the OptoMonitor II. 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 September 13, 2016 after a review of 131 days - within the typical 510(k) review window.

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 - K161263

510(k) Number K161263 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 05, 2016
Decision Date September 13, 2016
Days to Decision 131 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
6d slower than avg
Panel avg: 125d · This submission: 131d
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 34
Devices cleared under the same product code (DXO) and FDA review panel - the closest regulatory comparables to K161263.
TruWave Disposable Pressure Transducer
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PressureWire X
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TruWave Disposable Pressure Transducer
K171996 · Edwards Lifesciences, LLC · Oct 2017
PressureWire X Guidewire
K161171 · St. Jude Medical, Inc. · Aug 2016
Comet Pressure Guidewire
K151610 · Boston Scientific Corporation · Oct 2015
TruWave Disposable Pressure Transducer
K142749 · Edwards Lifesciences, LLC · Jan 2015