Cleared Special

K040698 - MASTERSCREEN CPX AND OXYCON CPX (FDA 510(k) Clearance)

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

K040698 · Viasys Healthcare GmbH · Anesthesiology device
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Apr 2004
Decision
21d
Days
Class 2
Risk

K040698 is an FDA 510(k) clearance for the MASTERSCREEN CPX AND OXYCON CPX. Classified as Calculator, Pulmonary Function Data (product code BZC), Class II - Special Controls.

Submitted by Viasys Healthcare GmbH (Yorba Linda, US). The FDA issued a Cleared decision on April 7, 2004 after a review of 21 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1880 - the FDA anesthesiology and respiratory device 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 Viasys Healthcare GmbH devices

Submission Details

510(k) Number K040698 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 2004
Decision Date April 07, 2004
Days to Decision 21 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
118d faster than avg
Panel avg: 139d · This submission: 21d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code BZC Calculator, Pulmonary Function Data
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1880
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 Anesthesiology devices follow this clearance model.