Cleared Special

K083750 - CAPNOSTAT / CAPNOFLEX CO2 SYSTEM

K083750 is an FDA 510(k) clearance for CAPNOSTAT / CAPNOFLEX CO2 SYSTEM, manufactured by Ge Medical Systems Information Technologies. The device is a Class 2 Cardiovascular device with product code MHX cleared through the Special 510(k) pathway after a 96-day FDA review.

K083750 · Ge Medical Systems Information Technologies · Cardiovascular device
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Mar 2009
Decision
96d
Days
Class 2
Risk

K083750 is an FDA 510(k) clearance for the CAPNOSTAT / CAPNOFLEX CO2 SYSTEM. Classified as Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) (product code MHX), Class II - Special Controls.

Submitted by Ge Medical Systems Information Technologies (Milwaukee, US). The FDA issued a Cleared decision on March 23, 2009 after a review of 96 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1025 - 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Ge Medical Systems Information Technologies devices

FDA 510(k) Submission Details - K083750

510(k) Number K083750 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 2008
Decision Date March 23, 2009
Days to Decision 96 days
Submission Type Special
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
29d faster than avg
Panel avg: 125d · This submission: 96d
Pathway characteristics
Modification to existing cleared device.

MHX Device Classification - Class 2, Special Controls

Product Code MHX Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1025
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 - MHX Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)

All 319
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