Cleared Special

K081776 - CONTINUOUS CARDIAC OUPUT MONITOR, TRUCCOM

K081776 is an FDA 510(k) clearance for CONTINUOUS CARDIAC OUPUT MONITOR, manufactured by Omega Critical Care Limited. The device is a Class 2 Cardiovascular device with product code DXG cleared through the Special 510(k) pathway after a 29-day FDA review.

K081776 · Omega Critical Care Limited · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2008
Decision
29d
Days
Class 2
Risk

K081776 is an FDA 510(k) clearance for the CONTINUOUS CARDIAC OUPUT MONITOR, TRUCCOM. Classified as Computer, Diagnostic, Pre-programmed, Single-function (product code DXG), Class II - Special Controls.

Submitted by Omega Critical Care Limited (East Kilbride, GB). The FDA issued a Cleared decision on July 22, 2008 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1435 - 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.

View all Omega Critical Care Limited devices

FDA 510(k) Submission Details - K081776

510(k) Number K081776 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 2008
Decision Date July 22, 2008
Days to Decision 29 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
96d faster than avg
Panel avg: 125d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

DXG Device Classification - Class 2, Special Controls

Product Code DXG Computer, Diagnostic, Pre-programmed, Single-function
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1435
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 - DXG Computer, Diagnostic, Pre-programmed, Single-function

All 97
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