Cleared Traditional

K131085 - CENTRAL VENOUS PRESSURE SYSTEM - MESPERE VENUS 1000 (FDA 510(k) Clearance)

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

K131085 · Mespere Lifesciences, Inc. · Cardiovascular device
Aug 2013
Decision
126d
Days
Class 2
Risk

K131085 is an FDA 510(k) clearance for the CENTRAL VENOUS PRESSURE SYSTEM - MESPERE VENUS 1000. Classified as Non-invasive Central Venous Manometer (product code PFA), Class II - Special Controls.

Submitted by Mespere Lifesciences, Inc. (Waterloo, On, CA). The FDA issued a Cleared decision on August 22, 2013 after a review of 126 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1140 - 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.

Submission Details

510(k) Number K131085 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 2013
Decision Date August 22, 2013
Days to Decision 126 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
14d faster than avg
Panel avg: 140d · This submission: 126d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PFA Non-invasive Central Venous Manometer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1140
Definition Measures The Central Venous Blood Pressure (cvp) Non-invasively At The Superior Vena Cava (right Heart) Based On Near Infrared Spectroscopy (nirs) Technology.
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.