Cleared Special

K151776 - Central Venous Pressure System (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K151776 · Mespere Lifesciences, Inc. · Cardiovascular device
Aug 2015
Decision
42d
Days
Class 2
Risk

K151776 is an FDA 510(k) clearance for the Central Venous Pressure System. Classified as Non-invasive Central Venous Manometer (product code PFA), Class II - Special Controls.

Submitted by Mespere Lifesciences, Inc. (Waterloo, CA). The FDA issued a Cleared decision on August 12, 2015 after a review of 42 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1140 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

Submission Details

510(k) Number K151776 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 2015
Decision Date August 12, 2015
Days to Decision 42 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
98d faster than avg
Panel avg: 140d · This submission: 42d
Pathway characteristics
Modification to existing cleared device.

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.